AstraZeneca has submitted an emergency approval to the US drug regulators for its COVID-19 antibody cocktail, which would be the first non-vaccine protection from the virus to be granted approval.
The biotech compound created by AstraZeneca, AZD7442, houses antibodies in a long-acting antibody combination for prophylaxis of symptomatic COVID-19. It is designed to contain the virus if someone becomes infected, which is different from COVID-19 vaccines that use the immune system of an individual to produce antibodies and cells that can fight off the virus.
Filing for the Emergency Use Authorization, the company has included data from its PROVENT Phase III trial, which showed a 77% reduction in risk of developing symptomatic COVID-19 without the need for a vaccine.
The therapy treatment, taken via two injections, could provide protection to those without a strong enough immune response to COVID-19 vaccines. It is designed to be effective for close to a year, providing protection from the virus.
AstraZeneca’s competitors to this line of treatment, Regeneron, Eli Lilly, and GSK (along with its partner Vir) are producing drugs using monoclonal antibodies to stop the disease worsening. Regeneron’s drug was approved by the FDA in September for preventing COVID-19 following exposure to those infected with the disease. In contrast, AstraZeneca’s emergency approval to the US drug regulators is outlined to prevent COVID-19 before exposure.
“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, BioPharmaceuticals R&D, AstraZeneca. “With this first global regulatory filing, we are one step closer to providing an additional option to help protect against COVID-19 alongside vaccines.”
Back in March, AstraZeneca agreed to supply the US with 500,000 doses of the then-experimental antibody therapy. It is unclear whether the US will choose to enlist more doses if emergency approval is granted by the FDA.