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  • USFDA extends review...

USFDA extends review of REGEN-COV to treat, prevent COVID-19: Regeneron Pharma

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-04-18T10:00:34+05:30  |  Updated On 20 April 2022 10:44 AM IST
USFDA extends review of REGEN-COV to treat, prevent COVID-19: Regeneron Pharma
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REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies designed specifically to block infectivity of SARS-CoV-2 using Regeneron's VelocImmune and VelociSuite technologies.

TarrytownRegeneron Pharmaceuticals, Inc. has announced that the U.S. Food and Drug Administration (USFDA) 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," Regeneron said in a release.

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.

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 dev

Read also: Sanofi, Regeneron get CHMP recommendation for Dupixent approval to treat severe asthma with type 2 inflammation in kids



regeneron pharmaregeneron pharma newsusfdaregen-covcasirivimabimdevimabcovid19coronavirus
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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