Regeneron’s COVID-19 therapy delays delay as AstraZeneca wins another victory
Regeneron’s COVID-19 therapy delays delay as AstraZeneca wins another victory

Regeneron’s COVID-19 therapy delays delay as AstraZeneca wins another victory

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Regeneron Pharmaceuticals announced Thursday, that of the United States Food and Drug Administration has expanded its review of the Biologics License Application (BLA) for the monoclonal antibody REGEN-COV, which treats COVID-19.

The decision comes after Regeneron submitted additional data from a prophylaxis trial. The delay was announced the same day that AstraZeneca received a Health Canada approval for its very similar prophylaxis COVID-19 treatment.

The REGEN-COV drug is a combination of two monoclonal antibodies, casirivimab and imdevimab. Both antibodies are designed specifically to block the infectivity of SARS-CoV-2. Regeneron created the treatment in collaboration with Roche and the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Contingency and Response. The drug became available in November 2020 as the pandemic continued to destroy the world.

Initially, REGEN-COV was approved by the FDA with an emergency use permit to treat inpatients with COVID-19. It was also used as prophylaxis or prophylaxis for patients at least 12 years of age who were not fully vaccinated or at high risk due to exposure or problems with the immune system. For a year and a half, the treatment was given to millions of patients worldwide.

Then, in January 2020, the FDA changed its Emergency use authorization of the drug to exclude regions where antibody treatment did not help humans infected with the local dominant COVID-19 variant. This exclusion affected the United States, so REGEN-COV is not currently approved for use in the United States.

Regeneron filed a BLA for REGEN-COV to help get the drug fully approved by the FDA. However, when the company submitted additional data from its prophylaxis trial to its BLA, the FDA considered it a “major change” to the original submission. As such, the agency said it is extending the BLA review. The FDA set a target date for action on July 13, 2022.

The good news for Regeneron is that the FDA did not require any further investigations to complete its review.

Regeneron hit this roadblock just like that AstraZeneca experienced success with a similar treatment. AstraZeneca’s Evusheld, which is also a COVID-19 prophylaxis combination of two monoclonal antibody drugs, was approved by Health Canada. Evusheld is made from antibody B cells extracted from donated blood from patients who have recovered from COVID-19. The treatment was successful in a phase III clinical trial, which showed a 77% reduction in the risk of developing symptomatic COVID-19 in patients 12 years of age and older.

“Evusheld is the only long-acting antibody combination with positive phase III data in the prevention and treatment of COVID-19. AstraZeneca is advancing with applications around the world for potential emergency use authorization or marketing authorization of Evusheld in both COVID-19 prophylaxis and treatment, “said AstraZeneca in a press release.

Despite its own setback and the success of a competitor, Regeneron has a positive outlook on its COVID-19 treatment as well as the other antibody treatments it is developing.

Regeneron remains committed to combating this pandemic and believes that monoclonal antibody therapies will continue to play an important role. a first-in-human clinical trial with one of these next-generation antibodies, “the company said.

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