AstraZeneca requests emergency authorisation for COVID-19 drug
pharmafile | October 5, 2021 | News story | Manufacturing and Production |
AstraZeneca has submitted an FDA request for Emergency Use Authorisation (EUA) for AZD7442, a long-acting antibody combination (LAAB) for the treatment of symptomatic COVID-19.
If the approval is granted, AZD7442 would be the first LAAB to receive an EUA for COVID-19 prevention. It has demonstrated a statistically significant reduction in the risk of developing symptomatic COVID-19 compared to placebo, and is the first LAAB with Phase III data to do so.
While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AZD7442 contains lab-made antibodies designed to linger in the body for months to contain the virus in case of infection, according to Reuters.
The drug is being studied in a comprehensive clinical trial programme for both the prevention and treatment of COVID-19 in over 9,000 participants. In the Phase III PROVENT trial, AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% compared to placebo.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, commented: “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.”
COVID-19 therapies based on the same class of antibodies are being developed by rival companies such as Regeneron, Eli Lilly, and GlaxoSmithKline with partner Vir, but AstraZeneca has taken the lead in COVID-19 prevention and treatment.
AstraZeneca said it expects US approval in the second half of this year, and discussions regarding supply agreements for AZD7442 are ensuing with the US government as well as others around the world.
Lina Adams
