Following two successful Phase 3 trials of more than 6,000 patients, the United States Food and Drug Administration (FDA) last week accepted the Regeneron Pharmaceuticals, Inc. anti-COVID-19 cocktail known as REGEN-COV for priority review.
REGEN-COV is a mix of the antibodies casirivimab and imdevimab, currently not approved by the FDA for use against COVID-19, but authorized for emergency use as treatment and post-exposure prophylaxis in certain high risk cases. Tests have thus far focused on its abilities to treat non-hospitalized patients already infected with SARS-CoV-2 and prevent symptomatic infection among asymptomatic household contacts of those infected with the COVID-19 causing virus.
Results of a separate study, which covered treatment of those hospitalized with COVID-19, are still pending.
Regeneron previously submitted a Biologics License Application (BLA) for the treatment, and now, the FDA said it intends to take action as of April 13, 2022. An advisory committee will also discuss the application ahead of this date, according to Regeneron. Meanwhile, those eligible continue to have access to the drug for free as part of a government-funded program. This was the result of funding for its development gained from the Biomedical Advanced Research and Development Authority (BARDA).
Simultaneously, regulatory submissions are underway in the European Union as well, and the European Medicines Agency (EMA) recently accepted a Marketing Authorization Application for the cocktail, although in Europe it operates under the name Ronapreve. That application would, if accepted, authorize the drug for use in treating non-hospitalized but infected patients, or as prophylaxis.