Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Description
Regeneron's REGEN-COV (Ronapreve) Monoclonal Antibody Cocktail (Ronapreve) combines two monoclonal antibodies, casirivimab, and imdevimab, explicitly designed to block the infectivity of SARS-CoV-2, the coronavirus that causes COVID-19. REGEN-COV was the first antibody therapy to demonstrate an antiviral effect in patients hospitalized with COVID-19.
Regeneron core technologies enable the rapid and efficient generation of these protective antiviral antibodies outside of the body, derived from genetically humanized mice or convalescent humans. The resulting antibodies correspond to the most potent antiviral antibodies that could be elicited by a vaccine or exposure to a pathogen.
The REGEN-COV antibody cocktail can be delivered via injection or IV, providing 'passive immunity and immediately protecting people from COVID-19. However, it must be re-administered to remain effective over time. These antibodies can also treat an existing infection, unlike vaccines, which can be used preventatively.
Regeneron's potent, virus-neutralizing antibodies that form the REGEN-COV Antibody Cocktail bind non-competitively to the critical receptor binding domain of the coronavirus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population, as detailed in Science, published on August 21, 2020.
On May 17, 2021, Regeneron announced data from a phase 3 study found 'patients treated with REGEN-COV had 4-day shorter duration of symptoms and significantly reduced viral load than placebo.'
On June 25, 2021, the Assistant Secretary for Preparedness and Response (ASPR) issued a notice saying 'ASPR is immediately pausing all distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with the existing supply of bamlanivimab at a facility for use under EUA 094) on a national basis until further notice. In addition, FDA recommends that health care providers nationwide use alternative authorized monoclonal antibody therapies and not use bamlanivimab and etesevimab administered together at this time. REGEN-COV2 and sotrovimab are alternative monoclonal antibody therapies currently authorized. In addition, based on similarities in vitro assay data presently available, REGEN-COV and sotrovimab are likely to retain activity against the P.1 or B.1.351 variants. Therefore, all treatment delivery sites can continue ordering REGEN-COV from the authorized distributor by following the existing ordering and reporting procedures.
On July 20, 2021, Roche announced that Japan's Ministry of Health, Labour, and Welfare had approved Ronapreve. Accordingly, the antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act.
The U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for REGEN-COV on July 30, 2021, to include post-exposure prevention in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting, such as in nursing homes or prisons.
As of August 10, 2021, REGEN-COV had not been FDA-Approved but has been Authorized for Emergency Use by the FDA as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. The FDA authorized REGEN-COV for post-exposure prophylaxis for COVID-19 on August 10, 2021. And the FDA published an updated Fact Sheet on September 17, 2021.
The NEJM published results from a phase 3 study in an Original Article on September 30, 2021, that concluded by saying 'REGEN-COV reduced the risk of Covid-19–related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo.'
U.S. facilities administering monoclonal antibodies can be found using the National Infusion Center Locator or the HHS Therapeutics Distribution locator. CMS billing information.
DrugBank: DB15691; KEGG D11938, D11939
New York-based Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) collaborates with Roche to increase the global supply of REGEN-COV. Regeneron is responsible for developing and distributing the treatment in the U.S. Roche is primarily responsible for the development and distribution of Ronapreve outside the U.S. Regeneron's August 2021 corporate update is linked here. Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) History
Regeneron scientists evaluated thousands of fully human antibodies produced by the Company's proprietary VelocImmune® mice, which have been genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19. As a result, Regeneron partnered with Roche on August 19, 2020, to increase COVID-19 Antibody Cocktail's global supply.
The concept that Monoclonal drug cocktails can prevent viral escape has been demonstrated for traditional antiviral drugs that treat HIV and other viruses. However, Regeneron now reports the fundamental realization that this can also be true for antibody-based therapies, as reported in a paper published in Science on August 21, 2020.
On October 7, 2020, the Company issued a 'Statement on REGN-COV2 Emergency Use Authorization Request: After our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for our COVID-19 Antibody Cocktail investigational antibody combination for COVID-19. Under our agreement with the U.S. government for the initial doses of COVID-19 Antibody Cocktail, if a EUA is granted, the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months.'
On August 4, 2021, the NEJM published an ORIGINAL ARTICLE: Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. Phase 3 clinical trial summary - Subcutaneous REGEN-COV2 prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the infected participants, REGEN-COV reduced the duration of symptomatic disease and a high viral load.
Leonard S. Schleifer, M.D., Ph.D., President and CEO of Regeneron, commented on September 14, 2020, "While vaccination remains the first line of defense to decrease the burden of COVID-19, REGEN-COV is a key tool that reduces the risk of hospitalization or death by 70% in high-risk individuals when given early in the course of the infection. Recently there has been a greater demand for REGEN-COV, and we will provide additional doses to the U.S. government as quickly as possible."
CDER Scientific Review Documents Supporting Emergency Use Authorizations for Drug and Biological Therapeutic Products for COVID-19 were updated by the U.S. FDA on September 9, 2021.
On September 23, 2021, the NEJM published the findings from a phase 3 clinical trial Original Investigation that concluded by saying, 'Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. In addition, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.'
The Company announced on October 14, 2021, the FDA had accepted for priority review a Biologics License Application (BLA) for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in specific individuals. The FDA has assigned a target action date of April 13, 2022. The BLA is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and safety of REGEN-COV to treat non-hospitalized patients already infected with the SARS-CoV-2 virus and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals (both uninfected and infected contacts). A second BLA submission focusing on treating patients hospitalized due to COVID-19 is expected to be submitted later in 2021.
Tarrytown, New York-based Regeneron (REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. The Company posted its 2q'21 presentation. This COVID-19 Antibody Cocktail's development and manufacturing has been funded partially with federal funds from the Biomedical Advanced Research and Development Authority under O.T. number: HHSO100201700020C. In addition, on June 16, 2021, CMS published various HCPCS code changes related to REGEN-COV COVID-19 monoclonal antibody treatments. Corporate Fact Sheet; Form 10K.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Availability
The European Medicines Agency human medicines committee started its 'rolling review' of data on REGN-COV2 antibody combination (casirivimab / imdevimab) in January 2021. In addition, on October 11, 2021, the EMA started evaluating an application for marketing authorization for Ronapreve (casirivimab / imdevimab). The applicant is Roche Registration GmbH.
Japan's Ministry of Health, Labour, and Welfare Approved Regeneron's REGEN-COV2 (casirivimab and imdevimab) antibody cocktail to treat patients with mild to moderate COVID-19 on July 20, 2021.
And the U.K.'s Medicines & Healthcare products Regulatory Agency published an update on August 20, 2021, for Ronapreve 120 mg/mL solution for injection or infusion, the first monoclonal antibody treatment (REGEN-COV) for the prevention and treatment of COVID-19 in the U.K.
The U.S. HHS announced on September 13, 2021, it is committed to helping ensure consistent availability of these critical drugs for current and future patients in all geographic areas of the USA. As such, HHS transitioned from a straightforward ordering process to a state/territory-coordinated distribution system similar to that used to distribute mAbs from November 2020 – February 2021. HHS will determine each state and territory's weekly amount of mAb products based on COVID-19 case burden and mAb utilization. State and territorial health departments will subsequently identify which sites in their respective jurisdictions receive products and the amount each location will receive.
Additionally, HHS announced on September 13, 2021, it amended the Public Readiness and Emergency Preparedness (PREP) Act declaration to provide liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns. By expanding PREP Act coverage to include these trained professionals to administer covered COVID 19 therapeutics, we are providing a pathway for increased access to COVID-19 therapeutics.
REGEN-COV has not been U.S. FDA approved but has been authorized for emergency use by the FDA under an Emergency Use Authorization. And, marketing authorization in Europe is pending.
The World Health Organization (WHO) announced its recommendation for REGEN-COV. The WHO announced on September 24, 2021, 'patients who are non-severe and at higher risk for hospitalization be treated and those that are severe or critical with seronegative status (those who have not developed natural antibodies against COVID-19 determined through accurate, rapid tests) be treated; as these two patient groups are the patients that stand to benefit most from the treatment.' "Dr. Janet Diaz, WHO head of clinical care, stated, "This is our first recommendation for a therapeutic for those patients with mild, moderate disease."
On October 8, 2021, the FDA confirmed REGEN-CoV was available in the state of Hawaii.
To schedule an appointment at a State of Florida site, click here. In Texas, REGEN-CoV sites are listed on this map. And in South Carolina. The U.S. government has set up a call center dedicated to providing patients and HCPs with information on monoclonal antibodies 1-877-332-6585.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Variant Effectiveness
Circulating SARS-CoV-2 coronavirus viral variants may be associated with resistance to monoclonal antibodies. Healthcare providers should review the Antiviral Resistance information in Section 15 of the Fact Sheet for details regarding specific variants and resistance. In addition, refer to the CDC website and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.
Multiple analyses have shown that the antibody cocktail retains potency against the main variants of concern circulating within the USA, including Delta, Gamma (Brazil), Beta (South Africa), and Mu (Colombia), with information available in the Fact Sheet for Healthcare Providers. Monitor SARS-CoV-2 betacoronavirus variant activity with Regeneron's COVID-19 Dashboard.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Indication
The REGEN-COV COVID-19 Monoclonal Antibody Cocktail Casirivimab and imdevimab (Ronapreve) are investigational therapies Authorized by the U.S. FDA for emergency use. Casirivimab and imdevimab are not FDA Approved for any use. The safety and effectiveness of casirivimab and imdevimab have not been fully established to treat COVID-19.
REGEN-COV (casirivimab and imdevimab) administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.
NIH Guidelines published on September 3, 2021, say the use of monoclonal antibodies when "there are logistical constraints" can prioritize unvaccinated people over those who have been vaccinated. The one exception is if the vaccinated person is immunocompromised. See the individual EUA for healthcare providers for details.
Regeneron's outpatient trial's clinical evidence suggests that monoclonal antibodies such as casirivimab and imdevimab have the most significant benefit when given early after diagnosis. However, in the U.S., other than clinical trials, casirivimab and imdevimab are not authorized for use in patients who are hospitalized or require oxygen therapy due to COVID-19, or for people currently using chronic oxygen therapy because of underlying comorbidity who need an increase in baseline oxygen flow rate due to COVID-19, says the Company.
The U.S. FDA revised the EUA for REGEN-COV (casirivimab and imdevimab, administered together) on August 10, 2021. Therefore, health care providers should review the Fact Sheet for detailed information about the use of REGEN-COV for post-exposure prophylaxis.
REGEN-COV also remains authorized to treat mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. However, prophylaxis with REGEN-COV2 is not a substitute for vaccination against COVID-19, says the FDA.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Indication For Women
Pregnancy: There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. REGEN-COV should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus REGEN-COV casirivimab and imdevimab injection therapy should be used during pregnancy only if the potential benefit justifies the mother and fetus's potential risk.
Nursing Mothers: There is currently no clinical experience using REGEN-COV (casirivimab and imdevimab) injection in COVID-19 patients breastfeeding. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for casirivimab and imdevimab injection and any potential adverse effects on the breastfed child from injection or the underlying maternal condition.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Dosage
On June 3, 2021, the U.S. Food and Drug Administration updated the Emergency Use Authorization for REGEN-COV (Ronapreve), lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab) is half the dose initially authorized. As part of the updated EUA, REGEN-COV2 should be administered by intravenous infusion; subcutaneous injections are an alternative when IV infusion is not feasible and would delay treatment. DRUG: Casirivimab; Imdevimab
Clinically monitor patients during dose administration and observe patients for at least 1 hour after intravenous infusion or subcutaneous dosing is complete. In addition, healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of REGEN-COV and mandatory requirements of the EUA and comply with the requirements of the EUA.
In the U.S., REGEN-COV can be administered by intravenous infusion (as short as 20 minutes) or by subcutaneous injection (4 injections), which is an alternative when the intravenous infusion is not feasible and would lead to a delay in treatment. In addition, it is now authorized as a co-formulated single vial or in individual vials to be administered together.
On August 10, 2020, the U.S. FDA confirmed REGEN-COV2 use as post-exposure prophylaxis for adults and pediatric individuals (12 years of age and older, weighing at least 40 kg). In addition, in those who require repeat dosing for ongoing exposure, REGEN-COV can also now be administered monthly.
Similar efficacy was observed with both doses (2,400 mg and 8,000 mg) by 1,197 patients reported to the Company on September 30, 2021.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) For Children
The EMA's Committee for medicines for children issued its opinion on the Company's pediatric investigation plans for casirivimab and imdevimab on October 11, 2021, which describe how the medication should be developed and studied for use in children, in accordance with the accelerated timelines for COVID-19 medicines.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Packaging
REGEN-COV is available in two distinct presentations: Dose pack bags: Dose pack bags will include a sufficient number of vials of casirivimab and imdevimab to prepare multiple doses. Co-formulated solution of REGEN-COV: The co-formulated solution of REGEN-COV contains two antibodies in a 1:1 ratio in a single dose vial consisting of 600 mg casirivimab and 600 mg of imdevimab per 10 mL (60 mg/60 mg per mL). Either presentation of REGEN-COV as described above may be prepared for intravenous infusion or subcutaneous injection.
The U.S. FDA published Temporary Alternative Packaging of Casirivimab and Imdevimab authorized to meet ongoing COVID-19 Public Health Demands on September 16, 2021. The Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR) confirmed on October 8, 2021, hospitals receiving this week's shipment of REGEN-COV should note that it will arrive in one of two packaging configurations: REGEN-COV Dose Packs (2 Vial) or Casirivimab and Imdevimab Co-Pack (2 vials per carton). ASPR says REGEN-COV in both packaging configurations may be used to prepare and administer intravenous infusions as well as subcutaneous injections. And a Quick Reference Guide was updated.
Medical information inquiries should be referred to Regeneron Medical Information at 1-844-734-6643.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Side Effects
The most common side effects were injection site reactions. The signs and symptoms of injection site reactions that occurred in at least 1% of subjects in the REGEN-COV group were skin redness (erythema), an uncomfortable, irritating sensation that creates an urge to scratch (pruritus), and ecchymosis (discoloration of the skin resulting from bleeding underneath, caused by bruising). There were no cases of severe hypersensitivity reactions, or potentially life-threatening allergic reactions (such as anaphylaxis), says the FDA.
People who had a previous severe allergic reaction to REGEN-COV should not use it again. Other important information for these trials, including different outcomes and side effects, is available in the health care provider fact sheet. In addition, on September 9, 2021, the EMA published COVID-19 treatment: Under Evaluation that is not explicitly authorized for patients with COVID-19.
Anyone can submit a report to VAERS, including parents and patients. And healthcare providers are required by law in the USA to report to VAERS.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) Payment Information
The REGEN-COV2 Coding and Reimbursement Guide offer an overview of the relevant codes, current as of June 2021, that may support reimbursement of the administration of REGEN-COV in outpatient settings. A review of relevant payment codes should be confirmed with each payer, as there may be variability in coding and documentation requirements.
In September 2021, the US Department of Health and Human Services' 9th amended the Public Readiness and Emergency Preparedness Act declaration provides liability protection to licensed pharmacists, pharmacy technicians, and pharmacy interns to administer covered COVID 19 therapeutics.
Regeneron REGEN-COV Monoclonal Antibody Cocktail (Ronapreve; Casirivimab and Imdevimab) News
October 14, 2021 - Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration had accepted a Biologics License Application for REGEN-COV to treat COVID-19 in non-hospitalized patients for priority review as prophylaxis in certain individuals.
October 11, 2021 - The EMA announced it will assess the benefits and risks of Ronapreve under a reduced timeline and could issue an opinion within two months, depending on the robustness of the data submitted and whether further information is required support the evaluation. Such a short timeframe is only possible because EMA's human medicines committee has already reviewed data on the medicine during a rolling review.
October 8, 2021 - The South Carolina Department of Health and Environmental Control announced that it encourages healthcare facilities, providers, and eligible patients to take advantage of monoclonal antibody treatment.
October 7, 2021 - The COVID-19 Treatment Guidelines Panel recommended the use of anti-SARS-CoV-2 mAbs for the treatment of mild to moderate COVID-19 and for post-exposure prophylaxis of SARS-CoV-2 virus infection in individuals who are at high risk for progression to severe COVID-19, as outlined in the Food and Drug Administration EUAs issued for the anti-SARS-CoV-2 mAbs.
October 7, 2021 - Morehead, KY-based St. Claire HealthCare reported an alarming daily high of 49 hospitalized COVID-19 patients during September 2021, but that number has been cut in half today. According to Will Melahn, MD, SCH Chief Medical Officer, the availability of monoclonal antibody therapies like REGEN-COV is playing a significant role in lowering hospitalization rates.
October 6, 2021 - The journal NEJM published a CORRESPONDENCE: Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. Providing only the relative risk measure may lead clinicians, patients, and laypeople to overestimate treatment efficacy.
October 2, 2021 - Local media reported Dr. William Agel, CMO for Cape Cod Hospital, and Cape Cod Healthcare had treated about 50 patients a week during a post-Labor Day surge. "It's been a great asset for the community."
September 29, 2021 - The NEJM published an ORIGINAL ARTICLE: REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19. This phase 2/3 study found REGEN-COV reduced the risk of Covid-19–related hospitalization or death from any cause, and it resolved symptoms and reduced the SARS-CoV-2 viral load more rapidly than placebo.
September 30, 2021 - Texas Governor Greg Abbott today announced that the Texas Division of Emergency Management will open a new COVID-19 therapeutic infusion center in Burnet in partnership with local officials. Texas previously opened 23 centers, in addition to about 200 private health providers across the state.
September 30, 2021 - Regeneron Pharmaceuticals, Inc. announced a trial assessing investigational REGEN-COV™ (casirivimab and imdevimab) in 1,197 patients hospitalized with COVID-19 met its primary endpoint. Trial results show that REGEN-COV significantly reduced viral load in patients hospitalized with COVID-19. In addition, they entered the trial without having mounted their antibody response (seronegative) and required low-flow or no supplemental oxygen (p=0.0172). The trial also had clinical results supporting the much larger UK RECOVERY trial in hospitalized patients, with numeric improvements observed across all clinical endpoints assessed. Roche also confirmed positive data from the phase II/III 2066 study investigating Ronapreve.
September 29, 2021 - Local media reported Yakima Valley Memorial Hospital in Washington is offering the REGEN-COV monoclonal antibody therapy with a referral from their primary care provider.
September 27, 2021 - The Dan Loesch radio program confirmed Texas bypasses the U.S. admin's restrictions on monoclonal antibody treatment allocations by procuring the product directly from the provider.
September 24, 2021 - The Regeneron antibody-drug cocktail REGEN-COV has been added to the World Health Organization's (WHO) list of treatments for COVID-19 patients. Dr. Janet Diaz, WHO head of clinical care, stated in a press release, "This is our first recommendation for a therapeutic for those patients with mild, moderate disease," because it reduces "the need for hospitalization if they are at high risk."
September 23, 2021 - The NEJM published an ORIGINAL ARTICLE: Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. In a phase 3 study, subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. In addition, REGEN-COV reduced the duration of symptomatic disease and a high viral load among the infected participants.
September 21, 2021 - Ynet News reported the Israeli Health Ministry said it would purchase Regeneron drug for Israelis suffering from mild and moderate COVID-19 symptoms.
September 19, 2021 - Houston-based BreatheMD posted unverified, self-reported Monoclonal Antibody Treatment results on 410 Patients. About 97% of Regen-CoV patients would recommend the treatment to a loved one.
September 14, 2021 - Regeneron Pharmaceuticals, Inc. announced that the U.S. Department of Health and Human Services and the Department of Defense would purchase 1.4 million additional doses of REGEN-COV (casirivimab) imdevimab) 1,200 mg doses at the cost of $2,100 per dose. The U.S. government confirmed it would continue to provide REGEN-COV at no cost to patients. In September 2021, Regeneron expects to begin delivering the additional REGEN-COV doses to the U.S. government, with the vast majority delivered in Q4 2021.
September 10, 2021 - Research presented found administration of Regeneron's REGEN-COV monoclonal antibody combination (casirivimab and imdevimab) reduced the risk of developing COVID-19 in participants with CVD and/or diabetes regardless of serostatus and was generally well tolerated. In addition, REGEN-COV treatment prevented symptomatic infection in participants with CVD (55% RRR) and/or diabetes (69% RRR), with effects independent of serostatus. "There is an unmet need for treatment options for individuals who are at an increased risk of moderate/severe COVID-19, including those with CVD and/or diabetes," the authors wrote.
September 7, 2021 - NASDAQ reported Regeneron fulfilled its second agreement with the U.S. government in the second quarter to manufacture and deliver 1.25 million doses of REGEN-COV at the lowest treatment dose authorized by the U.S. FDA, and in turn, recognized $2.59 billion in REG0EN-COV sales. The Company's shares have gained 40.7% in the year so far compared with the industry's growth of 2.8%.
August 30, 2021 - The Lancet published a research paper by EClinical Medicine: Casirivimab–Imdevimab treatment is associated with reduced hospitalization rates among high-risk patients with mild to moderate coronavirus disease-19. Interpretation - Among high-risk patients with mild to moderate COVID-19, casirivimab–imdevimab treatment was associated with a significantly lower hospitalization rate.
August 26, 2021 - Texas Governor Greg Abbott announced that the Texas Division of Emergency Management, in partnership with local officials, has expanded the number of locations where Regeneron's monoclonal antibodies are available to treat COVID-19 outpatient cases who have a referral from a doctor. This treatment is available at no cost to the patient.
August 24, 2021 - Queen's North Hawai'i Community Hospital is expanding the use of Regeneron's REGEN-COV2. This intravenous treatment is provided on an outpatient basis to COVID patients. Initial doses have been successfully given in the QNHCH emergency room, and QNHCH has dedicated a clinic to this new treatment.
August 20, 2021 - Regeneron Pharmaceuticals, Inc. announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency has granted Conditional Marketing Authorization for the casirivimab and imdevimab antibody cocktail, known as REGEN-COV™ in the U.S. and Ronapreve® in the U.K. and other countries, to prevent and treat acute COVID-19 infection. This announcement affects people in England, Scotland, and Wales, and Northern Ireland. The MHRA has also authorized emergency supply of the antibody cocktail.
August 19, 2021 - Texas Governor Greg Abbott today announced that the Texas Department of State Health Services and the Texas Division of Emergency Management would deploy additional medical personnel and launch more COVID-19 antibody infusion centers across the state over the next week. These infusion centers, equipped with Regeneron's monoclonal antibodies, will treat COVID-19 patients at no cost with therapeutic drugs that can prevent their condition from worsening and requiring hospital care.
August 17, 2021 - Texas Governor Abbott confirmed he is receiving Regeneron's monoclonal antibody treatment. "Governor Abbott is fully vaccinated against COVID-19, in good health, and currently experiencing no symptoms."
August 12, 2021 - Florida Gov. Ron DeSantis announced Thursday that the state would dispense REGEN-COV2 monoclonal antibodies through mobile clinics. The governor championed Regeneron's monoclonal antibody cocktail for those who have already gotten sick, saying it is "the most effective treatment that we've yet encountered for people who are infected with covid-19." To find locations to receive monoclonal antibody treatments around the entire state, please visit floridahealthcovid19.gov.
August 10, 2021 - The U.S. FDA authorized REGEN-COV2 monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19.
August 5, 2021 - Regeneron Pharmaceuticals, Inc. announced financial results for the second quarter of 2021 and provided a business update. The Company fulfilled its second agreement with the U.S. government to manufacture and deliver 1.25 million doses of REGEN-COV at the lowest treatment dose authorized by the U.S. FDA and recognized $2.59 billion of REGEN-COV sales. In addition, in June 2021, the FDA updated the REGEN-COV EUA by lowering the dose to 1,200 mg and permitting administration by subcutaneous injection when the intravenous infusion is not feasible.
August 4, 2021 - The U.S. NIH added REGEN-COV2 as a recommended treatment for non-hospitalized patients with mild to moderate COVID-19 at high risk for clinical progression.
August 4, 2021 - Regeneron Pharmaceuticals, Inc. announced that the New England Journal of Medicine published detailed positive results from a Phase 3 trial that assessed the ability of REGEN-COV™ (casirivimab and imdevimab) to prevent COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The trial met its primary endpoint, reducing the risk of symptomatic infections by 81%, with a 93% reduction of symptomatic infections after the first week and no dose-limiting toxicities observed.
July 30, 2021 - Regeneron Pharmaceuticals, Inc. announced that the U.S. FDA updated the EUA for the investigational COVID-19 antibody cocktail REGEN-COV. The authorization now includes post-exposure prevention in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and have been exposed to a SARS-CoV-2 infected individual, or who are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such nursing homes or prisons).
July 20, 2021 - Japan Approved Regeneron's casirivimab and imdevimab antibody cocktail (Ronapreve) to treat patients with mild to moderate COVID-19. This Approval is the first time the antibody cocktail has received full Approval to treat COVID-19.
June 16, 2021 - Regeneron Pharmaceuticals, Inc. confirmed positive results from the most significant trial assessing any monoclonal antibody treatment in patients hospitalized with severe COVID-19. The UK RECOVERY trial found that adding investigational REGEN-COV™ to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to standard care on its own.
June 9, 2021 - Canada Health Authorized By Interim Order (249830) Casirivimab and imdevimab for use concerning the COVID-19 pandemic, per section 5 of the Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19.
June 4, 2021 - Regeneron Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) updated the Emergency Use Authorization (EUA) for REGEN-COV™, lowering the dose to 1,200 mg (600 mg casirivimab and 600 mg imdevimab), which is half the dose initially authorized. As part of the updated EUA, REGEN-COV should be administered by intravenous infusion; subcutaneous injections are an alternative when IV infusion is not feasible and would delay treatment. REGEN-COV has not been approved by FDA but has been Authorized for emergency use.
June 4, 2021 - The U.S. government will purchase all REGEN-COV doses delivered by June 30, 2021, and may accept additional doses through September 30, 2021, at its discretion, up to a maximum amount of 1.25 million doses. Regeneron expects to deliver at least 1 million REGEN-COV doses to the U.S. government in the 2Q'21.
June 3, 2021 - The U.S. FDA issued a letter that stated: 'having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the February 25, 2021 letter in its entirety, authorizing revisions to the authorized use6 for REGEN-COV, a change in dosing of REGEN-COV from 2400 mg (1200 mg casirivimab and 1200 mg imdevimab) to 1200 mg (600 mg casirivimab and 600 mg imdevimab), and the addition of a new presentation consisting of a single vial containing casirivimab and imdevimab co-formulated in a 1:1 ratio for either intravenous infusion or subcutaneous injection. New conditions have been incorporated on providing samples of the authorized REGEN-COV to the U.S. Department of Health and Human Services upon request and the submission of certain genomic sequencing and virology information to the FDA by a specified date.'
May 26, 2021 - The U.S. HHS issued a Public Health Emergency saying 'REGEN-COV is likely to retain activity against the P.1 and B.1.351 variants. The U.S. FDA recommends that health care providers in Arizona, California, Florida, Indiana, Oregon, and Washington use this alternative authorized monoclonal antibody therapy until further notice.
May 5, 2021 - Roche India received emergency use authorization of the Central Drugs Standards Control Organisation for antibody cocktail (Casirivimab and Imdevimab) to treat mild to moderate COVID-19.
May 3, 2021 - Regeneron announced that positive Phase 3 data from trials evaluating two Regeneron medicines will be featured at the 2021 American Thoracic Society International Conference in the Breaking News: Clinical Trial Results in Pulmonary Medicine Scientific Symposium on May 17, 2021.
April 12, 2021 - Regeneron Pharmaceuticals, Inc. announced positive data from a Phase 3 trial (2069B) of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV™ (casirivimab with imdevimab) 1,200 mg administered via subcutaneous administration. REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint) and by 76% after the third day. The trial also demonstrated that REGEN-COV shortened symptom duration and markedly reduced viral levels.
April 9, 2021 - Regeneron Pharmaceuticals, Inc. announced that the newly updated National Institutes of Health (NIH) COVID-19 Treatment Guidelines strongly recommend that REGEN-COV™ (casirivimab with imdevimab) be used in non-hospitalized COVID-19 patients ("outpatients") at high risk of clinical progression. In addition, the NIH Category 'AIIa' is a 'strong' rating based on randomized trials.
March 23, 2021 - Regeneron announced phase 2 and 3 results for their antibody cocktail. REGEN-COV in high-risk non-hospitalized COVID-19 patients met its primary endpoint, showing the investigational REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% compared to placebo. Additionally, REGEN-COV significantly shortened the duration of symptoms by four days. The phase 2 dose-ranging showed significant and comparable viral reductions for all REGEN-COV doses tested, including as low as 300 mg.
February 4, 2021 - The European Medicine Agency (EMA) announced the human medicines committee is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab, and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
February 1, 2021 - The European Medicines Agency (EMA) announced the human medicines committee (CHMP) had started a 'rolling review' of data of the medicine known as REGN-COV2 antibody combination (casirivimab / imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID-19.
January 26, 2021 - Regeneron Pharmaceuticals, Inc. announced positive initial results from an ongoing Phase 3 clinical trial evaluating REGEN-COV™ (casirivimab and imdevimab antibody cocktail) used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient). Passive vaccination with REGEN-COV resulted in 100% prevention of symptomatic infection (8/223 placebo vs. 0/186 REGEN-COV) and approximately 50% lower overall rates of infection (symptomatic and asymptomatic) (23/223 placebo vs. 10/186 REGEN-COV).
January 22, 2021 - Local media reported Regeneron is confident that its popular antibody cocktail is still highly effective. That's because the Regeneron cocktail, which is not a vaccine but was designed to treat people who have already been infected with the coronavirus, is a mix of two different antibodies that fight COVID-19 instead of just one.
January 21, 2021 - The NEJM published an ORIGINAL ARTICLE - REGN-COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19. In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a more significant effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline.
January 12, 2021 - Regeneron Pharmaceuticals announced that the U.S. Department of Health and Human Services and the Department of Defense would purchase an additional supply of the casirivimab and imdevimab antibody cocktail non-hospitalized COVID-19 patients to meet the federal government's Operation Warp Speed goals.
December 29, 2020 - Regeneron Pharmaceuticals, Inc. announced encouraging initial data from an ongoing Phase 1/2/3 clinical trial of the Regeneron antibody cocktail, casirivimab and imdevimab, in hospitalized COVID-19 patients requiring low-flow oxygen. Under an agreement with the U.S. government, Regeneron produces approximately 300,000 doses (2,400 mg) for outpatient use under the EUA.
December 17, 2020 - The NEJM published a study that found 'In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. In addition, safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.'
November 21, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes 65 years of age or older or certain chronic medical conditions.
November 5, 2020 - Regeneron announced an update from the independent data monitoring committee (DMC) for the United Kingdom-based RECOVERY trial evaluating REGN-COV2 in hospitalized patients with COVID-19. The DMC reviewed available safety and efficacy data for the 15,545 total patients randomized, including the 325 patients in the arm randomized to receive either REGN-COV2 or control.
October 30, 2020 - Regeneron announced it received a recommendation from the independent data monitoring committee for the REGN-COV2 antibody cocktail treatment trials for COVID-19 to modify the current hospitalized patient trial.
October 28, 2020 - Regeneron Pharmaceuticals, Inc. announced positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. In addition, REGN-COV2 significantly reduced viral load and patient medical visits.
October 8, 2020 - Study: REGN-COV2 antibodies prevent and treat SARS-CoV-2 infection in rhesus macaques and hamsters.
October 7, 2020 - The Company issued a 'Statement on REGN-COV2 Emergency Use Authorization Request.'
October 2, 2020 - Regeneron Pharmaceuticals, Inc. confirmed that the Company provided a single 8-gram dose of REGNCOV2, a cocktail of two monoclonal antibodies, for U.S. President Trump. REGN-COV2 is an investigational COVID-19 therapy provided in response to an Individual Patient Investigational New Drug application, commonly known as 'compassionate use' request, from the President's physicians.
September 29, 2020 - Regeneron Pharmaceuticals, Inc. announced the first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 showing it reduced viral load and the time to alleviate symptoms in non-hospitalized patients with COVID-19.
August 3, 2020 - Non-peer-reviewed study: REGN-COV2 antibody cocktail prevents and treats SARS-CoV-2 infection in rhesus macaques and hamsters.
July 6, 2020 - Regeneron Pharmaceuticals, Inc. announced the initiation of a Phase 3 trial to evaluate REGN-COV2's ability to prevent infection among uninfected people who have had close exposure to a COVID-19 patient (such as the patient's housemate) and is being run jointly with the National Institute of Allergy and Infectious Diseases. REGN-COV2 has also moved into the Phase 2/3 portion of two adaptive Phase 1/2/3 trials testing the cocktail's ability to treat hospitalized and non-hospitalized patients with COVID-19.
June 11, 2020 - Regeneron announced the first clinical trial of REGN-COV2, it's investigational dual antibody cocktail to prevent and treat COVID-19.
REGEN-COV2 Monoclonal Antibody Cocktail (Casirivimab and Imdevimab) Clinical Trials
REGEN-COV continues to be studied in various clinical trials to assess safety, Tolerance, Pharmacokinetics, and Immunogenicity against COVID-19.
Phase 3 study - NCT04452318 - Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-CoV-2 Infection in Household Contacts of Individuals Infected With SARS-CoV-2 - published results in the NEJM on September 23, 2021.