AstraZeneca is nearly ready to seek approval for its COVID-19 antibody. Can it stick the landing?

Across the first phase of the pandemic, AstraZeneca went from being a good example of how pharma can step up in times of need to a warning that no good deed goes unpunished. Now, AstraZeneca has a shot at putting its vaccine woes behind it by carving out a space for a product that may address one of the remaining unmet COVID-19 needs in the West.

AstraZeneca teed up the opportunity last month when it linked its long-acting antibody cocktail to a 77% reduction in the risk of symptomatic coronavirus infection. The study enrolled 5,197 people who were expected to respond poorly or be intolerant to COVID-19 vaccines or who were at increased risk of SARS-CoV-2 infection, pointing to the potential for the candidate, AZD7442, to protect a group of individuals who have remained vulnerable even as vaccination rates have risen. 

After generating the data, AstraZeneca began work to seek emergency use authorization of AZD7442 on the strength of results from the phase 3 and another study that gave the antibody combination to people recently exposed to SARS-CoV-2. Now, AstraZeneca is nearing the submission date. 

“We’ve certainly shared the data with regulators, and we anticipate submitting the emergency use authorization very shortly,” AstraZeneca Vice President Mark Esser said at a press conference attended by Endpoints.

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Evidence that a single dose of the antibody combination protects vulnerable individuals for at least six months is a scientific success for AstraZeneca, which took molecules isolated by scientists at Vanderbilt University Medical Center from the B cells of people infected with SARS-CoV-2 in Wuhan, China, and made changes such as amino acid substitutions to extend their durability. AstraZeneca is aiming to provide up to 12 months of protection from a single shot of AZD7442.

The question now is whether AstraZeneca can bring AZD7442 to market and turn it into a successful product, both for patients and its finances. AstraZeneca’s vaccine program was held up in the U.S. by an adverse event—and reportedly blighted by poor communication with the FDA—and culminated in a data conflict disclosed publicly by the National Institute of Allergy and Infectious Diseases.   

If AstraZeneca can navigate the regulatory waters, it will then need to make the case for the use of a new type of tool in the response to COVID-19. Eli Lilly and Regeneron have already received green lights to use their anti-SARS-CoV-2 antibodies to protect people who have been exposed to the virus. AstraZeneca is looking to go a step further by establishing AZD7442 as an extra layer of protection in some people, regardless of whether they have recently encountered the coronavirus.