FDA Accepts REGEN-COV® (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19 Amid Global Cases Surpassing 240 Million

October 15, 2021 /BioonBIOON/ -- Currently, the COVID-19 pandemic outside China is still spreading rapidly. According to Baidu's "Real-time Novel Coronavirus Pneumonia Epidemic...Big DataReport》, as of 02:00 on October 15, 2021,Global cumulative confirmed cases exceed 240 million (240.15 million), with over 4.89 million deaths.

Recently, Regeneron announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the COVID-19 antibody cocktail therapy REGEN-COV (casirivimab and imdevimab) and granted it Priority Review: (1)For the treatment of non-hospitalized patients with COVID-19;（2）UsePrevention of COVID-19 in Certain Individuals。FDAA target action date of April 13, 2022, has been designated. The Agency has notified Regeneron that it is currently planning to convene an advisory committee meeting prior to that date.Meeting, to discuss the application. A second BLA is expected to be submitted later this year: for the treatment of hospitalized COVID-19 patients.

This BLA is supported by data from two positive Phase 3 trials involving more than 6,000 patients. These trials evaluated REGEN-COV: (1)For the treatment of non-hospitalized patients infected with the novel coronavirus (SARS-CoV-2)；（2）For asymptomatic household contacts of SARS-CoV-2-infected individuals (including both uninfected and infected contacts), to prevent symptomatic infection.

In the European Union (EU), regulatory submissions for REGEN-COV are also progressing. Earlier this week, the European Medicines Agency (EMA) accepted the Marketing Authorisation Application (MAA) for REGEN-COV (marketed as Ronapreve): for the treatment of infected non-hospitalised patients, or for the prevention of COVID-19 in certain individuals. Additionally, Regeneron plans to submit a Type II variation: for the use of REGEN-COV in the treatment of hospitalised patients with COVID-19.

In the United States, REGEN-COV has not yet obtainedFDANot approved, but has been granted an Emergency Use Authorization (EUA): for treatment and post-exposure prophylaxis in certain high-risk populations.

REGEN-COV antibody cocktail

REGEN-COV is an antibody cocktail therapy invented by Regeneron and co-developed with Roche, with Roche primarily responsible for development and supply outside the United States. REGEN-COV consists of two monoclonal antibodies (casirivimab and imdevimab) that target two independent, non-overlapping binding sites within the receptor-binding domain (RBD) of the SARS-CoV-2 spike (S) protein. They exert a synergistic effect to reduce the risk of viral escape and protect the population against viral variants harboring S protein mutations. Additionally, data from preclinical studies demonstrate that casirivimab and imdevimab retain neutralizing activity against key emerging variants.

In July this year, REGEN-COV received the world's first regulatory approval in Japan (full approval; brand name: Ronapreve) for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. Additionally, REGEN-COV has been granted conditional approval in the United Kingdom. Furthermore, REGEN-COV has been authorized for emergency use or temporary pandemic use in over 40 countries worldwide (including the United States, the European Union, India, Switzerland, and Canada). (Bioon.com)

Original Source:FDA Accepts REGEN-COV® (casirivimab and imdevimab) for Priority Review for Treatment and Prophylaxis of COVID-19