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Sunday, October 24th, 2021

AstraZeneca requests FDA emergency use authorization for long-acting COVID-19 antibody combination

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Although its COVID-19 vaccine was never authorized for use in the United States, AstraZeneca submitted a request with the U.S. Food and Drug Administration (FDA) this week seeking emergency use authorization (EUA) for its long-acting antibody (LAAB) combination for use against symptomatic COVID-19.

This combination, known as AZD7442, is meant as a preventative measure against the pandemic-spawning disease. In a trial of 5,197 participants — PROVENT Phase III — AZD7442 provided a risk reduction of 77 percent for development of symptomatic COVID-19 cases. Further, no cases of severe cases or deaths emerged among those treated by the LAAB, although three cases of severe COVID-19 and two deaths were experienced among those given placebos.

The cocktail is the first non-vaccine for COVID-19 modified to potentially provide long-lasting protection against COVID-19, and which has provided demonstrated capabilities in clinical trials, according to AstraZeneca. That could make it a game changer for those in need of protection but who are unlikely to gain adequate immune response from the usual vaccination course.

“Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D for AstraZeneca, said. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year.”

Supply agreements for the LAAB, following approval, are still being negotiated across the world. However, AZD7442 was developed with support from the U.S. Departments of Defense (DoD) and Health and Human Services (HHS). Under existing licensing terms, once approved for purchase, AstraZeneca will pay Vanderbilt University Medical Center single-digit royalties on all future net sales, for its original discovery of the treatment.