US filing for EUA for AZD7442 as COVID-19 prophylactic

UK pharma major AstraZeneca (LSE: AZN) has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19.

If granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It is the first LAAB with Phase III data demonstrating a statistically-significant reduction in the risk of developing symptomatic COVID-19 compared to placebo. Approval could be a major win for AstraZeneca, whose widely-used COVID-19 vaccine, Vaxzervria, has yet to be approved by the US regulator.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “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. 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.”