Monoclonal Antibody Treatments & Availability
SARS-CoV-2 Monoclonal Antibody Treatments And Availability
Monoclonal antibody (mAbs) products effectively against the SARS-CoV-2 virus variant Omicron. The U.S. HHS says mAb treatments block SARS-CoV-2 from entering cells in your body and limit the amount of the virus within your body. The main target of anti-SARS-CoV-2 coronavirus-neutralizing mAbs is the surface spike glycoprotein that mediates viral entry into host cells, says the U.S. NIH. mAbs targeting the spike protein have been shown to deliver benefits in reducing high-risk COVID-19 patient hospitalizations.
On January 11, 2022, the U.S. government distributed 226,996 doses to U.S. states, territories, and agencies. Since September 13, 2021, the U.S. government has distributed about 2.7 million mAbs. Find facilities administering mAbs using the National Infusion Center Locator or the HHS Therapeutics Distribution locator. And the national map displays locations that received mAds within several weeks. In addition, on December 30, 2021, the U.S. NIH confirmed the Approved antiviral Veklury (Remdesivir) could be used as a substitute for mAbs.
SARS-CoV-2 Monoclonal Antibody Effectiveness Against Variants (Omicron)
The U.S. NIH OpenData Portal reported on January 17, 2022, in vitro Therapeutic Activity against the Omicron variant. In addition, the CDC and Scripts publish updated coronavirus variant information in this Tracker App, as does the Stanford HIVDB team website. And the WHO publishes Tracking SARS-CoV-2 Variants on this webpage. And the UK's Health Security Agency publishes VoC data on this webpage.
SARS-CoV-2 Monoclonal Antibody Treatments Authorized in the U.S.
Regeneron's (NASDAQ: REGN) REGEN-COV is a potent, virus-neutralizing antibody that binds non-competitively to the critical receptor binding domain of the virus's spike protein. Currently authorized REGEN-COV® (casirivimab and imdevimab) antibodies have diminished potency versus Omicron but are active against the predominant Delta variant. Revised Fact Sheet published on December 20, 2021. During the week of January 11, 2022, a total of 55,324 doses were distributed in the U.S.
Eli Lilly's (NYSE: L.L.Y.) Bamlanivimab and etesevimab neutralizing IgG1 monoclonal antibody (mAb) combination is directed against the spike protein 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. Revised Fact Sheet published on December 20, 2021. During the week of January 11, 2022, a total of 44,880 doses were distributed in the U.S.
Vir Biotechnology, Inc. and GSK's Sotrovimab (Xevudy) is a fully human anti-SARS-CoV-2 monoclonal antibody selected based on its potential to neutralize the virus in vitro, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs. The EC authorized Sotrovimab on December 17, 2021. During the week of January 11, 2022, a total of 52,128 doses were distributed in the U.S.
AstraZeneca's COVID-19 Antibody combination Evusheld AZD7442 (tixagevimab and cilgavimab) achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint. As a result, the country of Bahrain Authorized EVUSHELD on November 14, 2021, and the U.S. FDA followed on December 8, 2021. During the week of January 11, 2022, a total of 44,880 doses were distributed in the U.S.
Previously, the U.S. NIH issued new guidelines on December 23, 2021, stating 'Remdesivir (Veklury) is expected to be active against the Omicron VOC, and the Panel added a 3-day course of intravenous remdesivir as another mAbs treatment option.
SARS-CoV-2 Monoclonal Antibody Treatments Authorized Globally
Brii Biosciences Limited amubarvimab / romlusevimab combination (BRII-196/BRII-198) is approved in China but not in the U.S. for the treatment in adults and certain pediatric patients with a mild and typical type of COVID-19. In addition, it has confirmed its effectiveness against the Omicron variant. Authorization is pending in the U.S.A.
Celltrion Healthcare Remsima®, the world's first monoclonal antibody biosimilar, has received marketing authorization in drug approval agencies in 110 countries. In the U.S., this product's name is Inflectra®.
The EMA issued marketing authorization for the monoclonal antibody Regkirona (regdanvimab, CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and are at increased risk of progressing to severe COVID 19.
Monoclonal Antibodies - Experimental
Eli Lilly's Bebtelovimab (LY-CoV1404, LY3853113)) is a highly potent, neutralizing SARS-CoV-2 spike glycoprotein receptor-binding domain-specific antibody. In pseudovirus studies, LY-CoV1404 retains potent neutralizing activity against numerous variants, including B.1.617.2, B.1.1.7, B.1.351, B.1.427/B.1.429, P.1, and B.1.526, binding to these variants in the presence of their underlying RBD mutations (which include K417N, L452R, E484K, and N501Y). LY-CoV1404 entered clinical trials as part of Lilly's BLAZE-4 study in patients with mild-to-moderate COVID-19 illness.
Vyrologix (Leronlimab) is a humanized monoclonal antibody targeted against the CCR5 receptor found on T lymphocytes of the human immune system. The CCR5 receptor plays a central role in modulating immune cell trafficking to sites of inflammation. The first patient was dosed in a pivotal Phase 3 trial (CD16) in Brazil for critically ill COVID-19 patients on October 25, 2021.
Immunome, Inc. IMM-BCP-01 is a three-antibody cocktail targeting non-overlapping regions of the Spike protein. It elicits multi-modal activity in preclinical testing, including ACE2 and non-ACE2 dependent neutralization, and inducing natural viral clearance mechanisms, such as complement activation and phagocytosis.
Aridis Pharmaceuticals's AR-701 is a cocktail of two fully human immunoglobulin G1 (IgG1) mAbs, consists of AR-703 and AR-720 mAbs, each neutralizes coronaviruses using distinct mechanisms of action, namely inhibition of viral fusion and entry into human cells (AR-703) and blockage of viral binding to the human 'ACE2' receptor (AR-720). In addition, AR-703 binds to the 'S2' stalk region of spike proteins from beta coronaviruses, including the SARS-CoV2 variants (beta, gamma, delta, epsilon), and binds to the Omicron variant with no loss in affinity compared to the original Wuhan strain.
SARS-CoV-2 mAbs Payment in the U.S.
During the COVID-19 public health emergency, the U.S. government pays for these infusions (when furnished consistent with their respective EUAs the same way it covers and pays for COVID-19 vaccines. CMS identified specific code(s) for each COVID-19 monoclonal antibody product and specific administration code(s) for Medicare payment.
SARS-CoV-2 mAbs and Cancer Patients
The National Comprehensive Cancer Network® (NCCN) published expert consensus recommendations on vaccination and pre-exposure prophylaxis of COVID-19 in people with cancer including information on the use of human mAbs on January 4, 2022. Patients with blood cancers (stem cell transplantation, engineered cellular therapy) are more likely to have inadequate responses to COVID-19 vaccination. The NCCN committee states that it is reasonable to prioritize these patients to receive Evusheld (tixagevimab plus cilgavimab).
SARS-CoV-2 Monoclonal Antibodies News
January 14, 2022 - The JAMA Network published the results of a phase 3 clinical study that reported treatment with subcutaneous casirivimab and imdevimab (REGEN-COV) mAbs compared with placebo significantly reduced the incidence of symptomatic COVID-19 among recently exposed, asymptomatic individuals. A related Editorial, intravenous infusion of REGEN-COV, compared with placebo, led to an approximately 70% relative reduction in hospitalization and all-cause mortality, with absolute rates of 1% vs 3.2% in the 1200-mg treatment and placebo groups, respectively.
January 14, 2022 - The WHO has also conditionally recommended the use of sotrovimab for treating mild or moderate COVID-19 in patients who are at high risk of hospitalization and those unvaccinated. Sotrovimab is an alternative to casirivimab-imdevimab (REGEN-COV), a mAbs cocktail recommended by WHO in September 2021.
January 13, 2022 - Vir Biotechnology, Inc. and GSK announced the submission of an application to the U.S. FDA requesting an amendment to the EUA for the mAbs sotrovimab to include intramuscular administration.
January 11, 2022 - The Utah Department of Health stated in a press release: Given the extreme scarcity of COVID-19 mAbs treatments due to the prevalence of the omicron variant, we are re-evaluating the calculator and comparing it to current data to determine what factors best capture those at most at-risk for severe disease, hospitalization, and death. Nobody automatically qualifies for treatment based on their race/ethnicity.
January 9, 2022 - AbCellera announced non-peer-reviewed preclinical data confirmed that the investigational antibody bebtelovimab, which is currently in Phase 2 clinical trials with Eli Lilly and Company, maintains both full and potent neutralization activity against the Omicron variant and all other known SARS-CoV-2 variants of concern. The breadth of reactivity to amino acid substitutions present among current VOC together with broad and potent neutralizing activity and the relatively conserved epitope suggests that LY-CoV1404 has the potential to be an effective therapeutic agent to treat all known variants causing COVID-19.
January 5, 2022 - The U.S. NIH published an update to the COVID-19 Treatment Guidelines Panel's Statement on Tixagevimab Plus Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis for SARS-CoV-2 Infection.
January 4, 2022 - The National Comprehensive Cancer Network® (NCCN) published significant updates to the expert consensus recommendations on vaccination and pre-exposure prophylaxis of COVID-19 in people with cancer. The NCCN committee states that it is reasonable to prioritize these patients for Evusheld (tixagevimab plus cilgavimab) before patients with solid tumor cancers in the event of a limited supply.
January 3, 2022 - Celltrion Group announced results for its cocktail therapy candidates including neutralization data against the Omicron variant (B.1.1.529). In an experiment conducted in partnership with the National Institutes of Health, CT-P63 showed strong neutralizing activity against the Omicron variant based on structural analysis by X-ray crystallography and neutralization data from pseudo- virus testing.
December 31, 2021 - A non-peer-reviewed study: Structural basis of SARS-CoV-2 Omicron immune evasion and receptor engagement - reveals electrostatic remodeling of the interactions within the spike and those formed between the Omicron RBD and human ACE2, likely explaining enhanced affinity for the host receptor relative to the prototypic virus.
December 31, 2021 - The Texas Department of State Health Services has requested additional allocations of sotrovimab, a mAbs therapy that is proven to be effective in fighting the Omicron variant of COVID-19 and reducing hospitalizations. In addition, the agency also requested that the federal government continue to supply the State of Texas with Regeneron and bamlanivimab, monoclonal antibody treatments for other strains of COVID-19 that have also proven to help reduce hospitalizations across the state.
December 31, 2021 - The U.S. HHS published updated guidelines regarding the allocation of bamlanivimab/etesevimab and REGEN-COV therapeutics States and Territories can continue to order both products.
December 30, 2021 - The U.S. NIH published updated COVID-19 Treatment Guidelines Panel's Statement on Therapies for High-Risk, Non-hospitalized Patients With Mild to Moderate COVID-19.
December 29, 2021 - The U.S. Department of HHS announced it would pause allocations of bamlanivimab/etesevimab and REGEN-COV COVID-19 therapeutics to states or territories within regions of the country that have greater than 80% prevalence of the Omicron variant based on CDC NOWCAST data.
December 27, 2021 - An international research team with the Howard Hughes Medical Institute at the University of Washington School of Medicine in Seattle identified four antibody classes that can neutralize not only the Omicron coronavirus variant but also other variants from related coronaviruses. The omicron variant has 37 mutations in the spike protein, which it uses to latch onto and invade cells. Broadly neutralizing mAbs recognizing RBD epitopes conserved among SARS-CoV-2 variants and other sarbecoviruses may prove key to controlling the ongoing pandemic and future zoonotic spillovers.
December 27, 2021 - The U.S. government distributed 202,330 mAbs to the states.
December 23, 2021 - A non-peer-reviewed study authored by researchers associated with the National Research Center for Epidemiology and Microbiology stated 'heterodimeric molecule could be a promising drug candidate for treatment for COVID-19 caused by virus variants of concern.'
December 23, 2021 - The U.S. NIH issued an interim statement is to provide guidance on which individuals might receive the most significant benefit from anti-SARS-CoV-2 therapeutics for treatment or prevention of COVID-19.
December 23, 2021 - AstraZeneca US EVUSHELD mAbs was found to retain neutralization activity against the Omicron variant according to new authentic 'live' virus neutralization data from University College Oxford, UK, and Washington University School of Medicine, St. Louis, US. EVUSHELD's Inhibitory Concentration 50 (IC50), a measure of neutralizing potency of an antibody, was 273 ng/ml and 147 ng/ml in the Oxford and Washington University studies, respectively.
December 21, 2021 - Aridis Pharmaceuticals, Inc. announced today that its fully human monoclonal antibody cocktail AR-701 is broadly reactive against the Omicron and other COVID-19 (SARS-CoV-2) variants, SARS, MERS, and seasonal ('common cold') human coronaviruses.
December 16, 2021 - A non-peer-reviewed study: The effect of an anti-SARS-CoV-2 monoclonal antibody, bamlanivimab, on the endogenous immune response to COVID-19 vaccination - These findings are pertinent for informing public health policy with results that suggest a complementary role for COVID-19 mAbs with COVID-19 vaccines and that the benefit of receiving COVID-19 vaccination at the earliest opportunity outweighs the minimal effect on the endogenous immune response due to prior prophylactic COVID-19 mAb infusion.
December 16, 2021 - AstraZeneca announced EVUSHELD, a long-acting antibody combination to prevent COVID-19, retained neutralizing activity against the Omicron SARS-CoV-2 variant.
December 9, 2021 - China's National Medical Products Administration approved the amubarvimab / romlusevimab combination therapy (BRII-196/BRII-198).
December 8, 2021 - The U.S. F.D.A. announced the emergency authorization of the Evusheld mAbs for the pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.
December 3, 2021 - The Lancet published the WHO international standard for SARS-CoV-2 antibodies to determine protection markers.
December 3, 2021 - The U.S. F.D.A. revised the EUA of bamlanivimab and etesevimab to additionally authorize the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death.
December 1, 2021 - A non-peer-reviewed study found the Sotrovimab (VIR-7831/VIR-7832) epitope does not overlap with mutational sites in current variants of concern and continues to be highly conserved among circulating sequences consistent with the high barrier to resistance observed in vitro.
December 1, 2021 - Immunome, Inc. announced that it had conducted an assessment of the reported mutations in the Omicron (B.1.1.529) variant. Based on mapping those mutations and activity against previous and current C.D.C. variants of concern, Immunome expects its antibody cocktail, IMM-BCP-01, to neutralize the Omicron variant.
November 29, 2021 - Immunome, Inc. announced that it had submitted an Investigational New Drug Application to the U.S. F.D.A. for IMM-BCP-01, a three-antibody cocktail, for the treatment of COVID-19.
November 21, 2021 - The U.S. F.D.A. issued a EUA REGEN-COV to be administered together to treat mild to moderate COVID-19 in certain adults and pediatric patients.
November 16, 2021 - A non-peer-reviewed study found repeated monthly administration of 1200 mg SC REGEN-COV was well-tolerated with low immunogenicity and showed a substantial risk reduction in COVID-19 occurrence.
November 15, 2021 - Global Times reported a neutralizing monoclonal antibody combination therapy (BRII-196/BRII-198) is expected to become the first in China to get approval for market use in December 2021. The combination therapy is co-developed by Tsinghua University, the Third People's Hospital of Shenzhen, and Brii Biosciences, with headquarters in China and the U.S.
November 14, 2021 - Bahrain's National Health Regulatory Authority approved the emergency use of the EVUSHELD to combat COVID-19.
November 12, 2021 - GlaxoSmithKline and Vir Biotechnology announced the primary endpoint was met in the COMET-TAIL Phase III trial evaluating intramuscular administration of sotrovimab for early treatment of COVID-19.
November 11, 2021 - The E.M.A.'s human medicines committee recommended authorizing Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. Ronapreve and Regkirona are the first monoclonal antibody medicines to receive a positive opinion from the CHMP for COVID-19 and join the list of COVID-19 products that have received a positive opinion since Veklury (remdesivir) was recommended for authorization in June 2020. In addition, on Nov. 12th, the European Commission approved Ronapreve™ in the European Union and other countries.
November 8, 2021 - Regeneron Pharmaceuticals, Inc. announced additional positive results from a Phase 3 trial: a single dose of REGEN-COV (1,200 mg subcutaneous) reduced the risk of COVID-19 by 81.6% during the pre-specified follow-up period (months 2-8), maintaining the 81.4% risk reduction previously reported during month 1; During the 8-month assessment period there were 0 hospitalizations for COVID-19 in the REGEN-COV group and 6 in the placebo group.
November 3, 2021 - Open Forum Infectious Disease published: Bamlanivimab efficacy in older and high B.M.I. outpatients with Covid-19 selected for treatment in a lottery-based allocation process. Finding - The effectiveness of bamlanivimab in reducing Covid-19 related hospitalizations in patients ≥ 65 or with B.M.I.≥ 35 suggests a mortality benefit.
November 1, 2021 - A Research Letter: Effectiveness of REGEN-COV antibody cocktail against the B.1.617.2 (delta) variant of SARS-CoV-2: A cohort study; was published by the Journal of Internal Medicine. Faster resolution of symptoms by Day 3 in the cocktail group indicates an enhanced benefit against worsening in high-risk patients receiving the cocktail early in the disease course. In addition, the neutralizing efficacy of the antibody cocktail against pseudoviral variants also confirms its ability to block the entry of the delta variant, similar to a previous report, thus reducing the viral load.
October 27, 2021 - An Original Article published by the NEJM concluded by saying: Among high-risk patients with mild-to-moderate Covid-19, sotrovimab reduced the risk of disease progression. However, no safety signals were identified in this clinical trial.
October 27, 2021 - The JAMA Network published a News Article: Monoclonal Antibodies for COVID-19 Preexposure Prophylaxis Can't Come Fast Enough for Some People.
October 14, 2021 - The JAMA Network published a Research Letter describing how nurses in Michigan reduced E.R. visits and hospitalizations of high-risk COVID-19 patients by coordinating at-home administration of neutralizing mAbs during 2021. Our real-world approach leveraged the ability of nurses to identify, triage, and coordinate home M.A.B. infusions while successfully preventing high-risk patients from progression to severe disease and hospitalization.
October 11, 2021 - Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442 long-acting antibody combination achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild-to-moderate symptomatic COVID-19.
October 8, 2021 - The U.S. government published a Public Health Alert: Shipment of the bamlanivimab/etesevimab monoclonal antibody therapeutic to Hawaii has paused. The US Centers for Disease Control and Prevention has identified that the delta plus variant circulates with a frequency exceeding 5% in Hawaii. And results from in vitro assays suggest that bamlanivimab and etesevimab administered together are not active against this variant.
October 8, 2021 - South Carolina announced 32,686 COVID-19 patients in South Carolina had been treated with monoclonal antibodies. No anaphylactic reactions or other serious adverse events have been reported.
October 4, 2021 - South Dakoda-based S.A.B. Biotherapeutics announced that the first patient had been dosed with SAB-185 in the Phase 3 ACTIV-2 COVID-19 clinical trial. SAB-185 is a fully human, specifically targeted, broadly neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. SAB-185 is the second agent to graduate to Phase 3 and the first polyclonal antibody therapeutic candidate in ACTIV-2, which is evaluating multiple investigational agents to treat early symptomatic COVID-19 in non-hospitalized individuals.
October 4, 2021 - The E.M.A. started evaluating an application from Celltrion Healthcare Hungary Kft for marketing authorization for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19.
September 30, 2021 - Regeneron Inc. issued a press release highlighting a REGEN-CoV clinical trial that met the primary endpoint, showing REGEN-COV significantly reduced viral load within seven days of treatment. This trial was conducted in patients hospitalized with COVID-19 who did not require high-flow oxygen or mechanical ventilation at baseline.
September 24, 2021 - The WHO issued a conditional recommendation for Regeneron's monoclonal antibody cocktail REGEN-COV (casirimivab and imdevimab) for patients with nonsevere COVID-19 who are at high risk for hospitalization and for people who have severe and critical infections who have no antibodies to SARS-COV-2.
September 23, 2021 - The NEJM published an ORIGINAL ARTICLE - Subcutaneous REGEN-COV Antibody Combination to Prevent Covid-19. CONCLUSIONS: Subcutaneous REGEN-COV prevented symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection in previously uninfected household contacts of infected persons. Among the phase 3 study participants who became infected, REGEN-COV reduced the duration of symptomatic disease and the duration of a high viral load.
September 20, 2021 - A new study was published by the journal Nature: High genetic barrier to SARS-CoV-2 polyclonal neutralizing antibody escape. Optimally elicited human polyclonal antibodies against SARS-CoV-2 should be resilient to substantial future SARS-CoV-2 variation and may confer protection against potential future sarbecovirus pandemics.
September 16, 2021 - The U.S. F.D.A. confirmed it concluded that revising this E.U.A. is appropriate to protect public health or safety under section 564(g)(2) of the Act; F.D.A. is reissuing the August 27, 2021 letter in its entirety also to authorize bamlanivimab and etesevimab administered together for emergency use as post-exposure prophylaxis in certain adults and pediatric individuals.
September 9, 2021 - The European Medicines Agency published updated safety reports for potential 19 antibody treatments for COVID-19 patients in the European Union.
August 26, 2021 - U.K. medicines regulator has approved Ronapreve (REGEN-COV) for COVID-19 treatment. This product is already licensed for emergency use in more than 20 countries – including the U.S., Japan, and India.
Note: This content is aggregated from various sources and fact-checked by healthcare providers. Review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under a E.U.A. for details regarding specific variants and resistance. You should also refer to the C.D.C. website (https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proporti...) and information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.