U.S. FDA Extends Review of Biologics License Application for REGEN-COV (casirivimab and imdevimab) for Treatment and Prophylaxis of COVID-19
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has extended by three months its review of the Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which Regeneron has submitted additional data from its completed prophylaxis trial that the FDA has accepted for review. The FDA considers the submission of these additional data to be a Major Amendment to the BLA and has provided a new target action date of July 13, 2022. The FDA has not requested any new studies to complete its review of the current BLA at this time.
REGEN-COV, an investigational monoclonal antibody therapy, first became available to U.S. patients in November 2020, via the FDA`s Emergency Use Authorization (EUA) process for medicines that may help diagnose, treat or prevent a life-threatening disease when adequate and approved alternatives are not available. In January 2022, FDA amended the EUA to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment. Therefore, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions.
Regeneron remains committed to fighting this pandemic and believes that monoclonal antibody therapies will continue to play an important role. The company is progressing investigational next generation antibodies that are active against the currently circulating variants of concern, and has initiated a first-in-human clinical trial of one of these next generation antibodies.
The development and manufacturing of REGEN-COV have been funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S. Department of Health and Human Services` Office of the Assistant Secretary for Preparedness and Response, under OT number: HHSO100201700020C.
About REGEN-COV
REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron`s proprietary VelocImmune® and VelociSuite® technologies. Regeneron invented the antibody cocktail and is collaborating with Roche, who is primarily responsible for development and distribution outside the U.S., where it is known as Ronapreve.
Since REGEN-COV first became available to U.S. patients under the EUA process, it has been used to treat millions of people with COVID-19 in the U.S. and around the globe. The EUA is for the duration of the declaration that circumstances exist justifying the authorization of the emergency uses under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. REGEN-COV is not approved by the FDA.
About Regeneron`s VelocImmune Technology
Regeneron`s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron`s President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create approximately one in five of all original, FDA-approved or authorized fully human monoclonal antibodies currently available. This includes REGEN-COV (casirivimab and imdevimab), Dupixent (dupilumab), Libtayo (cemiplimab-rwlc), Praluent (alirocumab), Kevzara (sarilumab), Evkeeza (evinacumab-dgnb) and Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn).