October 5, 2021 – AstraZeneca PLC said it has asked U.S. regulators for EUA for an antibody drug that has shown strong efficacy in preventing symptomatic Covid-19 in a small group of people who have chronic conditions.
AstraZeneca said in August that, while not a vaccine, the antibody combination would be delivered as a shot with the aim of preventing Covid-19 symptoms for a small group of people who have chronic diseases and other conditions that may render vaccines less effective.
AstraZeneca executives and the principal trial investigator said in August the primary target for the antibody will be people who take Covid-19 vaccines but don’t get the hoped-for immune boost because of these preconditions. It could also be used by people who have been advised not to take the vaccine (for instance, those at risk of allergic reactions) or as an extra precaution for fully vaccinated people.
While the drug showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials, over 75% of the participants in the trial had chronic disease, including conditions that could render vaccines less effective.
This antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford.
EUA from the FDA, if granted, would make the long-acting antibody cocktail a first-of-its kind preventive option, according to the Wall Street Journal.
The company earlier hoped the therapy could be used to treat acute Covid-19 symptoms and keep people already exposed to the virus out of the hospital, but in clinical trials, the drug failed to meet those expectations – a setback for AstraZeneca.
Full trial results have not yet been published or reviewed by independent researchers. AstraZeneca has said laboratory tests suggest the drug is effective against the highly transmissible Delta variant.
AstraZeneca is discussing trial data and potential authorization filings with European and U.K. medicines regulators, respectively, a company spokeswoman said. She said submissions for possible use in other countries also are under consideration, depending on supplies of the drug.