Bamlanivimab COVID-19 Antibody Treatment Description
Eli Lilly's Bamlanivimab (LY-CoV555) neutralizing IgG1 monoclonal antibody (mAb) directed against the spike protein of the SARS-CoV-2 coronavirus. Bamlanivimab was designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially preventing and treating COVID-19.
Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies to prevent and treat COVID-19. Lilly scientists rapidly developed the antibody in less than three months after being discovered by AbCellera and tested by the NIAID Vaccine Research Center scientists.
Bamlanivimab is authorized in the USA by the U.S. FDA to treat mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Therefore, Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within ten days of symptom onset.
On April 16, 2021, Lilly requested Bamlanivimab's single-use authorization in the USA to be withdrawn. In addition to Bamlanivimab, a second Lilly antibody, LY-CoV016, which binds a different epitope in the SARS-CoV-2 spike region, has been added to the BLAZE-1 clinical trial. Etesevimab (LY-CoV016, also known as JS016) is a recombinant fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. In addition, point mutations were introduced into the native human IgG1 antibody to mitigate effector function.
On June 25, 2021, the Assistant Secretary for Preparedness and Response (ASPR) announced, 'it 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.
The NEJM published an Orginal Article on July 14, 2021, that concluded, 'Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19–related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load.' And the U.S. NIH published updated Anti-SARS-CoV-2 Monoclonal Antibodies guidance on August 4, 2021.
On August 27, 2021, a US Public Health Emergency notice issued bamlanivimab and etesevimab administered together are currently authorized for use in the states of Colorado, Connecticut, Illinois, Indiana, Iowa, Kansas, Maine, Massachusetts, New Hampshire, Michigan, Minnesota, Missouri, Montana, Nebraska, North Dakota, Ohio, Rhode Island, South Dakota, Utah, Vermont, Wisconsin, and Wyoming. Therefore, effective today, ASPR will resume 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 to these states.
The U.S. FDA confirmed on August 27, 2021, the changes to the authorized use of the monoclonal antibodies bamlanivimab and etesevimab, administered together.
On September 15, 2021, the U.S. NIH published COVID-19 Treatment Guidelines Panel’s Statement on Bamlanivimab 700 mg Plus Etesevimab 1,400 mg for the Treatment of Mild to Moderate COVID-19 in Nonhospitalized Patients with intravenous infusion in regions where the combined frequency of potentially resistant SARS-CoV-2 virus variants is low.
The U.S. FDA expanded the EUA on September 16, 2021, for bamlanivimab 700 mg and etesevimab 1400 mg administered together to include post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection. Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific and medical officer, and president of Lilly Research Laboratories, said in a related press release, "We're pleased that this expansion will help us provide antibody therapies as post-exposure prophylaxis to help prevent the spread of COVID-19 to some of the most at-risk individuals in the U.S." The expanded EUA is based on data from BLAZE-2 (NCT04497987), a study conducted in partnership with the U.S. NIAID.
Patients and physicians can visit the NICA Infusion Center Locator or the HHS Therapeutics Distribution locator to find a potential therapy location.
Etesevimab Monoclonal Neutralizing Antibody
Etesevimab (LY-CoV016, JS016) is a recombinant fully human monoclonal neutralizing antibody. It specifically binds to the SARS-CoV-2 surface spike protein receptor-binding domain high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. In addition, point mutations were introduced into the native human IgG1 antibody to mitigate effector function. The U.S. FDA published a revised Fact Sheet on March 20, 2021.
Eli Lilly licensed etesevimab from Junshi Biosciences after jointly developed by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Science. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and globally as initiated Phase 1b/2 trials in COVID-19 patients. Junshi Biosciences (HKEX: 1877; SSE: 688180) leads development in Greater China, while Lilly leads growth in the rest of the world.
A Phase 2 study assessing the efficacy and safety of bamlanivimab alone and bamlanivimab with other neutralizing antibodies versus placebo to treat symptomatic low-risk COVID-19 in the outpatient setting (BLAZE-4. NCT04634409) has completed enrollment.
Bamlanivimab COVID-19 Antibody Treatment History
On November 9, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together. They are authorized to treat mild to moderate COVID-19 in adult patients 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 progressing to severe COVID-19 and/or hospitalization. The issuance of a EUA does not constitute FDA approval of a product. The COVID-19 Treatment Guidelines Panel reviewed the available evidence from the published data on bamlanivimab for the treatment for COVID-19 and the FDA fact sheet that supported the EUA, said the NIH.
The company announced a new purchase agreement with the US government on December 2, 2020, for $812.5 million. The bamlanivimab doses will be delivered through January 31, 2021, with at least 350,000 additional doses given in December 2020.
On January 26, 2021, Lilly announced new data show treatment with the neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) reduces the risk of COVID-19 hospitalizations and death by 70%. "These exciting results, which replicate positive Phase 2 data in a much larger set of patients, add valuable clinical evidence about the role neutralizing antibodies can play in fighting this pandemic. While the preliminary nature of Phase 2 results from COVID-19 neutralizing monoclonal antibodies may have limited acceptance of treatment, these Phase 3 data further strengthen the available evidence," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, in a press statement.
The U.S. FDA announced a EUA granting on February 9, 2021, for Lilly's investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together. This therapy is authorized to treat mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. This EUA states Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within ten days of symptom onset. The FDA has also authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes.
On March 11, 2021, the EMA announced its review process had launched.
On May 11, 2021, the US Centers for Medicare & Medicaid Service (CMS) confirmed the investigational monoclonal antibody therapies are available under FDA emergency use authorization (EUA): Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021). The FDA authorized the use of these monoclonal antibody therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply: the patient has a positive COVID-19 test result, and the patient is at high risk for progressing to severe COVID-19, hospitalization, or both.
Based in Indiana, Eli Lilly (LLY) is a global healthcare leader who unites caring with discovery to create medicines that make life better for people worldwide. To learn more about Lilly, please visit www.lilly.com.
Bamlanivimab COVID-19 Antibody Treatment Indication
Bamlanivimab (LY-CoV555) is indicated to prevent or mitigate the progression of COVID-19 infection caused by the SARS-CoV-2 coronavirus. As of November 9, 2020, Bamlanivimab was authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older, weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within ten days of symptom onset, says Lilly.
The U.S. FDA EUA includes 65 years of age or older or certain chronic medical conditions. Bamlanivimab is not authorized for hospitalized patients due to COVID-19 or requires oxygen therapy due to COVID-19. Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. In August 2021, the FDA published an updated Fact Sheet.
AbCellera (Nasdaq: ABCL) announced on September 16, 2021, the U.S. FDA had expanded the EUA for bamlanivimab (LY-CoV555) 700 mg administered with etesevimab (LY-CoV016) 1400 mg to include post-exposure prophylaxis to prevent SARS-CoV-2 infection or symptomatic COVID-19. The neutralizing antibodies can now be used together to treat high-risk individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in an institutional setting, including a nursing home or prison.
Bamlanivimab COVID-19 Treatment Side Effects
Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).
Bamlanivimab COVID-19 Antibody Treatment Safety Information
The U.S. FDA has not Approved Bamlanivimab and etesevimab together and bamlanivimab alone FDA for any use. It is unknown if bamlanivimab and etesevimab together or bamlanivimab alone are safe and effective for the treatment of COVID-19. There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use. Infusion-related reactions have been observed with the administration of bamlanivimab.
There are insufficient data on the use of bamlanivimab during pregnancy. Therefore, Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the mother and fetus's potential risk. In addition, there are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Therefore, breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.
On September 9, 2021, the EMA published COVID-19 treatment: Under Evaluation that is not Authorised specifically for patients with COVID-19.
Bamlanivimab COVID-19 Antibody Treatment Guidelines
Eli Lilly says, 'If you’ve recently been diagnosed with COVID-19, you may have a new treatment option: bamlanivimab. The research shows that taking this drug may help limit the number of viruses in the body for certain people. This may help their symptoms improve sooner — and they may be less likely to need to go to the hospital. But bamlanivimab is a new drug that’s still being studied, so there’s a lot that scientists don’t know about the benefits and risks. Together, you and your doctor can decide if this treatment is right for you.'
The revised NIH COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of Bamlanivimab for the Treatment of COVID-19 indicates the optimal dose of bamlanivimab plus etesevimab for the treatment of COVID-19 has not yet been established, and the dose currently recommended by the EUA may be revised as data from clinical trials emerge.
On August 20, 2021, the U.S. FDA and ASPR announced the Authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, bamlanivimab, which is currently authorized for emergency use only when administered together with etesevimab. As a result of this extension, unopened vials of bamlanivimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and maybe stored for an additional 6 months from the labeled date of expiry.
Bamlanivimab COVID-19 Antibody Allocations
A current list of countries with a purchase agreement and regulatory authorization is found on this Eli Lilly webpage. The quantity listed is approximate, based on medical allocations, and – as noted in the process – the actual volume shipped could be more or less, depending on what the country accepted for purchase and any additional quantities that were available for purchase if another country did not accept its full allocation.
As of August 27, 2021, the U.S. FDA posted a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab administered together are currently authorized, and a list of states, territories, and U.S. jurisdictions in which bamlanivimab and etesevimab, administered together, are not currently authorized and will periodically update both lists as new data and information become available. The FDA will determine this considering current variant frequency data, trends in variant frequency over time, and the precision of the estimates and information regarding emerging variants of concern.
The U.S. HHS announced on September 3, 2021, it is immediately implementing the following changes to help promote optimal and equitable use of the available supply of monoclonal antibodies while we continue efforts to procure additional products: Limiting immediate orders and shipment only to administration sites with HHSProtect accounts and current utilization reporting; Reviewing all orders for alignment with utilization, currently estimated at 70% of orders.
Bamlanivimab COVID-19 Antibody Treatment News
September 19, 2021 - Junshi Biosciences (HKEX: 1877; SSE: 688180) announced the U.S. FDA had expanded the emergency use authorization for etesevimab (JS016/LY-CoV016) 1,400 mg and bamlanivimab (LY-CoV555) 700 mg administered together to include post-exposure prophylaxis in certain individuals 12 years of age and older who have not been fully vaccinated against COVID-19 or are not expected to mount an adequate immune response to complete vaccination, and have been exposed to someone infected with SARS-CoV-2 or who are at high risk of exposure in institutional settings, including nursing homes and prisons.
September 16, 2021 - Carl Hansen, Ph.D., CEO and President of AbCellera, confirmed in a press release, “More than 535,000 patients have been treated with bamlanivimab alone or together with etesevimab, potentially keeping more than 25,000 patients out of the hospital and saving more than 10,000 lives. With this expanded authorization, these antibodies, which have been shown to be effective against the highly contagious Delta variant, can now be used to protect some of the most at-risk people exposed to the virus.”
September 15, 2021 - Eli Lilly and Company (NYSE: LLY) announced an additional purchase by the U.S. government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. As part of the agreement, Lilly will supply 388,000 doses of etesevimab to complement doses of bamlanivimab previously purchased by the U.S. government, with approximately 200,000 doses expected to ship Q3 2021 and the remaining to be shipped in Q4.
September 2, 2021 - The Assistant Secretary for Preparedness and Response and the Food and Drug Administration within the U.S. Department of Health and Human Services are committed to ensuring timely and transparent communication regarding the COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.
August 27, 2021 - The U.S. Department of Health and Human Services confirmed it was resuming Eli Lilly's COVID-19 antibody cocktail therapy supply to states with low levels of SARS-CoV-2 coronavirus variants. The Office of the Assistant Secretary for Preparedness and Response had paused the distribution of bamlanivimab and etesevimab together (EUA 094) and etesevimab alone to pair with existing bamlanivimab as of June 25, 2021. This decision is related to the prevalence of the P.1 (Brazil) variant and the B.1.351 (South Africa) variant now circulating in these states.
August 20, 2021 - The US Assistant Secretary for Preparedness and Response and the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services announced the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, bamlanivimab, which is currently authorized for emergency use only when administered together with etesevimab.
August 3, 2021 - Eli Lilly and Company (NYSE: LLY) announced financial results for the second quarter of 2021.
July 15, 2021 - The NEJM published an Original Article: Monoclonal Antibodies
and Vaccine Boosts. In this audio interview conducted on July 13, 2021, the editors discuss new studies of combination monoclonal therapy against Covid-19 and new evidence on vaccine boosts. This editorial is related to the phase 3 study's results published on July 14th.
July 14, 2021 - A study published by the NEJM concluded, 'Among high-risk ambulatory patients, bamlanivimab plus etesevimab led to a lower incidence of Covid-19–related hospitalization and death than did placebo and accelerated the decline in the SARS-CoV-2 viral load.'
June 25, 2021 - The FDA immediately pauses 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.
June 3, 2021 - The JAMA published an Orginal Investigation which concluded, 'Among residents and staff in skilled nursing and assisted living facilities, treatment during August-November 2020 with bamlanivimab monotherapy reduced the incidence of COVID-19 infection.' This randomized phase 3 clinical trial included 966 participants and staff at US skilled nursing. It assisted living facilities with at least 1 confirmed SARS-CoV-2 index case and negative at baseline for SARS-CoV-2 infection and serology enrolled from August to November 2020. The incidence of COVID-19 infection among those treated with bamlanivimab vs. placebo was 8.5% vs. 15.2%, respectively, a statistically significant difference.
May 26, 2021 - The U.S. HHS issued a Public Health Notice: Distribution of this product to Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon, and Washington has been paused. Please see the updates for additional information.
May 17, 2021 - The University of Pittsburgh School of Medicine and UPMC physician-scientists published a new study in Open Forum Infectious Diseases that found Bamlanivimab monoclonal antibody monotherapy was associated with reduced hospitalizations and mortality within 28 days among outpatients with mild-moderate COVID-19. After adjustment for propensity to receive treatment, bamlanivimab treatment was associated with a significantly reduced risk-adjusted odds of hospitalization or mortality within 28 days (OR 0.40, 95% confidence interval [95% CI] 0.24 to 0.69; p<.001). Bamlanivimab treatment was also associated with a significantly lower risk-adjusted odds of hospitalization or emergency department visit without hospitalization (OR 0.54, 95% CI 0.35 to 0.82; p=.004).
April 16, 2021 - Eli Lilly and Company requested the U.S. Food and Drug Administration revoke the Emergency Use Authorization for bamlanivimab (LY-CoV555) 700 mg alone. Lilly made this request due to the evolving variant landscape in the U.S. and the full availability of bamlanivimab and etesevimab together. This request is not due to any new safety concerns.
April 12, 2021 - Eli Lilly and Company announced Lilly and the U.S. government have agreed to modify the purchase agreement of bamlanivimab alone and focus on the supply of bamlanivimab and etesevimab together. Additionally, the bamlanivimab and etesevimab agreement has been modified to enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government already purchased. This terminates the purchase agreement for bamlanivimab alone and cancels the remaining 350,856 doses scheduled to be delivered to the US government by the end of March 2021.
April 8, 2021 - The U.S. NIH announced data are emerging on the currently available anti-SARS-CoV-2 monoclonal antibodies, including preliminary data from a Phase 3 trial of casirivimab plus imdevimab in vitro susceptibility of SARS-CoV-2 variants to anti-SARS-CoV-2 monoclonal antibodies. After reviewing the available data, the COVID-19 Treatment Guidelines Panel (the Panel) has updated its recommendations on anti-SARS-CoV-2 monoclonal antibodies in outpatients with mild to moderate COVID-19 who are at high-risk disease progression. Also, the Panel notes that, because of an increasing number of reports of variants that are resistant to bamlanivimab alone, this product will no longer be distributed by the U.S. government.
March 29, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint. Also, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5, and 7 in the SARS-CoV-2 virus viral load.
March 17, 2021 - Endpoint News reported the US government is no longer distributing Eli Lilly’s bamlanivimab into California, Arizona, and Nevada because of the prevalence of a viral variant that is not susceptible to the monoclonal antibody, FDA acting commissioner Janet Woodcock announced in a webinar with the AMA.
March 11, 2021 - The EMA’s human medicines committee has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab, developed by Indiana-based Eli Lilly and Company, to be used in combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.
March 10, 2021 - Eli Lilly announced new data from the BLAZE-1 Phase 3 study, demonstrating bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together significantly reduced COVID-19 related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19.
March 5, 2021 - Eli Lilly and Company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab. The opinion advises that bamlanivimab alone and bamlanivimab administered together with etesevimab can be used to treat confirmed COVID-19 in patients aged rs and older who do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
February 26, 2021 - Eli Lilly and Company announced the U.S. government has agreed to purchase a minimum of 100,000 doses of bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg together; Bamlanivimab and etesevimab together recently received emergency use authorization for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization.
February 23, 2021 - The COVID-19 Treatment Guidelines Panel’s Statement on the Emergency Use Authorization of the Bamlanivimab Plus Etesevimab Combination for the Treatment of COVID-19: Bamlanivimab and etesevimab are neutralizing monoclonal antibodies that bind to different but overlapping epitopes in the receptor-binding domain of the spike protein of the SARS-CoV-2 coronavirus.
February 17, 2021 - LETTER TO THE EDITOR published by Wiley: Bamlanivimab to treat COVID‐19 in solid organ transplant recipients: An early single‐center experience. In this study, following the administration of Bamlanivimab to solid organ transplant patients diagnosed with mild‐moderate COVID‐19 in a non‐hospitalized setting, no patient experienced symptom worsening or required hospitalization.
February 9, 2021 - The U.S. FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab 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 who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The EUA use includes treatment for 65 years of age or older or certain chronic medical conditions.
February 4, 2021 - The European Medicine Agency 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. The committee will carry out two separate reviews: the casirivimab/imdevimab combination and another for bamlanivimab/etesevimab.
January 27, 2021 - Eli Lilly and Company, Vir Biotechnology, Inc., and GlaxoSmithKline plc announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19.
January 26, 2021 - Eli Lilly announced Bamlanivimab (LY-CoV555) 2800 mg and etesevimab (LY-CoV016) 2800 mg together significantly reduced COVID-19-related hospitalizations and deaths in high-risk patients recently diagnosed with COVID-19. Across 1,035 patients, there were 11 events (2.1 percent) in patients taking therapy and 36 events (7.0 percent) in patients taking placebo, representing a 70 percent risk reduction (p= 0.0004).
January 21, 2021 - Eli Lilly and Company's Bamlanivimab (LY-CoV555) significantly reduced the risk of contracting symptomatic COVID-19 among residents and staff of long-term care facilities, according to the Phase 3 BLAZE-2 COVID-19 prevention trial. After all of the study participants reached 8 weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 (the primary endpoint) in the bamlanivimab treatment arm versus placebo (odds ratio 0.43, p=0.00021).
January 21, 2021 - JAMA Network Original Investigation - Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19. A Randomized Clinical Trial Conclusions and Relevance: 'Among nonhospitalized patients with mild to moderate COVID-19 illness, treatment with bamlanivimab and etesevimab, compared with placebo, was associated with a statistically significant reduction in SARS-CoV-2 viral load at day 11. No significant difference in viral load reduction was observed for bamlanivimab monotherapy.
December 28, 2020 - Governor Greg Abbott and the Texas Department of State Health Services are alerting nursing facilities to the availability of monoclonal antibody therapies that can be used to treat residents who have been diagnosed with COVID-19. Commissioner John Hellerstedt, MD, urges facility administrators to work with their medical directors and treating physicians to consider the use of monoclonal antibodies whenever appropriate.
December 18, 2020 - Eli Lilly and Company announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, collaborating with major local institutions in the state of New Mexico. Conducting the study in New Mexico will allow collecting data on the effectiveness and safety of bamlanivimab in a real-world setting that includes a diverse population and spans both rural and urban environments.
December 11, 2020 - JAMA article: he investigational neutralizing IgG1 monoclonal antibody bamlanivimab (LY-CoV555; Lilly) has been granted an FDA Emergency Use Authorization (EUA) for treatment of recently diagnosed mild to moderate COVID-19 in patients who are ≥12 years old, weigh at least 40 kg, and are at high risk for progressing to severe disease and/or hospitalization.
December 2, 2020 - The U.S. government has purchased 650,000 additional doses of the neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The doses will be delivered through January 31, 2021, with at least 350,000 extra doses delivered in December 2020. Bamlanivimab recently received emergency use authorization to treat mild to moderate COVID-19 patients at high risk for progressing to severe COVID-19 and/or hospitalization. This purchase brings the total doses purchased by the U.S. government to 950,000.
November 24, 2020 - 1st patient receiving Covid-19 antibody infusion at El Paso Convention Center hospital announced. The alternate care site was provided with 1,000 doses of bamlanivimab, a monoclonal antibody therapy created by Eli Lilly & Company recently approved for emergency use by the FDA.
November 20, 2020 - Health Canada granted authorization under the Interim Order Respecting the Importation, Sale, and Advertising of Drugs for Use concerning COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12 years of age or older with mild to moderate COVID-19 who weigh at least 40 kg and are at high risk of progressing to severe COVID-19 illness and/or hospitalization.
November 19, 2020 - Texas Governor Greg Abbott updated the distribution of bamlanivimab, the Eli Lilly & Company monoclonal antibody therapy for COVID-19. The Texas Department of State Health Services has allocated this initial shipment of bamlanivimab to acute care hospitals across Texas.
November 13, 2020 - A new study in Italy found Baricitinib as possessing anti-viral and anti-cytokine efficacy. This limited study showed a 71% (95% CI 0.15-0.58) mortality benefit in 83 patients with moderate-severe SARS-CoV-2 pneumonia, with few drug-induced adverse events, including a large elderly cohort (median age 81 years).
November 9, 2020 - Eli Lilly announced the U.S. FDA granted Emergency Use Authorization for the investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. The authorization allows for the distribution and emergency use of bamlanivimab administered via a single intravenous infusion.
October 28, 2020 - Eli Lilly and Company announced an initial agreement with the U.S. government to supply 300,000 vials of bamlanivimab (LY-CoV555) 700 mg, an investigational neutralizing antibody, for $375 million. The initial agreement is for delivery over the two months following authorization and also provides the option for the U.S. government to purchase up to an additional 650,000 vials through June 30, 2021.
October 26, 2020 - The ACTIV-3 clinical trial is being run by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). It is the only study evaluating the efficacy of bamlanivimab in hospitalized COVID-19 patients. Based on an updated dataset from the trial reviewed on October 26, no additional COVID-19 patients in this hospitalized setting will receive bamlanivimab.
October 14, 2020 - Lilly announced it continues to communicate with the trial sponsor regarding the recommendation from the independent data safety monitoring board (DSMB) of the ACTIV-3 clinical trial to pause the study's enrollment. ACTIV-3 evaluates Lilly’s investigational neutralizing antibody bamlanivimab (LY-CoV555) as a treatment for COVID-19 in hospitalized patients.
October 8, 2020 - Junshi Biosciences announced that its global partner Eli Lilly and Company announced positive interim data on combination therapy with neutralizing antibodies JS016 (LY-CoV016) LY-CoV555 in recently diagnosed patients with mild-to-moderate COVID-19 illness.
October 7, 2020 - Lilly provides a comprehensive update on the progress of SARS-CoV-2 neutralizing antibody programs.
October 1, 2020 - Non-peer-reviewed study: LY-CoV555, a rapidly isolated potent neutralizing antibody, protects in a non-human primate model of SARS-CoV-2 infection.
September 16, 2020 - Lilly announced proof of concept data from an interim analysis of the BLAZE-1 clinical trial, showing a reduced hospitalization rate for patients treated with LY-CoV555.
August 3, 2020 - Lilly Initiates Phase 3 Trial of LY-CoV555 to prevent COVID-19 at Long-Term Care Facilities in Partnership with the National Institute of Allergy and Infectious Diseases (NIAID).
June 1, 2020 - Eli Lilly and Company announced patients had been dosed in the world's first study of a potential antibody treatment designed to fight COVID-19.
Bamlanivimab COVID-19 Antibody Treatment Clinical Trials
Eli Lilly continues to test Bamlanivimab in clinical trials.