U.S. FDA Gives Authorization to AstraZeneca Anti-Body Cocktail for Covid-19

AstraZeneca’s long-acting antibody combination authorized for emergency use in the US for pre-exposure prophylaxis (prevention) of Covid-19. Only antibody therapy authorized in US for pre-exposure prophylaxis. Pivotal phase III data showed robust efficacy and long-term protection with one dose in high-risk population

Media Release:

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 AstraZeneca’s long-acting antibody combination (tixagevimab co-packaged with cilgavimab called AZD7442), has received emergency use authorization (EUA) in the US for pre-exposure prophylaxis (prevention) of Covid-19, with first doses expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA for AstraZeneca’s long-acting antibody combination for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to Covid-19 vaccination, as well as those individuals for whom Covid-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

What the medical experts say

Myron J. Levin, MD, professor of Pediatrics and Medicine, University of Colorado School of Medicine, US, and principal investigator on the PROVENT trial, said: “Millions of people in the US and around the world remain at serious risk for Covid-19 because their immune systems do not generate a sufficient immune response, even after receiving all recommended doses of vaccine. I am excited to offer my patients AstraZeneca’s long-acting antibody combination as an easily-administered new option that provides long-lasting protection that could help them return to their everyday lives.”

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “We are proud to play a leading role in fighting the Covid-19 pandemic and, with AstraZeneca’s long-acting antibody combination, we now have the first antibody therapy authorized in the US to prevent Covid-19 symptoms before virus exposure, while also providing long lasting protection with a single dose.  AstraZeneca’s long-acting antibody combination neutralizes all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant. We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of AstraZeneca’s long-acting antibody combination.”

Brian Koffman, MDCM (retired), MS Ed, co-founder, executive vice president and chief medical officer of the CLL (Chronic Lymphocytic Leukemia) Society, US, said: “One of the primary questions I keep getting asked by patients is ‘When can I hug my grandchildren again?’ As a physician and person with a weakened immune system, l am filled with hope now that AstraZeneca’s long-acting antibody combination will soon be available to those who can’t count on vaccination alone to provide the protection they need.”

 Lotis Ramin, country president of AstraZeneca Philippines said, “The U.S. Food and Drug Administration’s EUA of AstraZeneca’s long-acting antibody combination for the prevention of Covid-19 is an important milestone globally. We are proud of this development and the opportunity it brings to support the unmet needs of vulnerable patients.  There are a number of patients with comorbidities who might have weakened immune system and at greater risk for severe Covid-19 infection in the Philippines. We have already initiated engagements with the relevant health authorities to provide them with the latest evidence. Recent data from the Phase III PROVENT trial showed a robust efficacy profile and AstraZeneca’s long-acting antibody (LAAB) combination has so far demonstrated  protection of up to six months against Covid-19 in high risk and immune-compromised patients.”

 AstraZeneca’s long-acting antibody is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorized in the US for Covid-19 pre-exposure prophylaxis and the only Covid-19 antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab).

About 2% of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine.1,2 About seven million people in the US are immuno-compromised and may benefit from AstraZeneca’s long-acting antibody combination for pre-exposure prophylaxis of Covid-19.1,3,4 This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis.5-9

The primary data supporting the AstraZeneca’s long-acting antibody combination EUA are from the ongoing PROVENT Phase III pre-exposure prevention trial, which showed a statistically significant reduction (77% at primary analysis, 83% at median six-month analysis) in the risk of developing symptomatic Covid-19 compared to placebo, with protection from the virus continuing for at least six months. More follow-up is needed to establish the full duration of protection provided by AstraZeneca’s long-acting antibody combination. Data from the Phase III STORM CHASER post-exposure trial and the AstraZeneca’s long-acting antibody combination Phase I trial also supported the EUA. AstraZeneca’s long-acting antibody combination was well-tolerated in the trials.

AstraZeneca’s long-acting antibody combination and SARS-CoV-2 variants

Studies are underway to provide information on the impact of the new Omicron variant (B.1.1.529) on AstraZeneca’s long-acting antibody combination.10,11 Of the Omicron binding site substitutions relevant to AstraZeneca’s long-acting antibody combination that have been tested to date in preclinical assays, none have been associated with escape from AstraZeneca’s long-acting antibody combination neutralisation.10,11 In vitro findings demonstrate AstraZeneca’s long-acting antibody combination neutralizes other recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.10

AstraZeneca’s long-acting antibody combination is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.

AstraZeneca has agreed to supply the US government with 700,000 doses of AstraZeneca’s long-acting antibody combination. The U.S. government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.

AstraZeneca is progressing with filings around the globe for potential emergency use authorization or conditional approval of AstraZeneca’s long-acting antibody combination in both Covid-19 prophylaxis and treatment.

AZD7442 is not yet approved for use in the Philippines. (/)


Featured logo of AstraZeneca credit to @infdisease_news on Twitter.

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