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The US FDA Extends BLA Review for Regeneron’s REGEN-COV for the Treatment and Prophylaxis of COVID-19

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The US FDA Extends BLA Review for Regeneron’s REGEN-COV for the Treatment and Prophylaxis of COVID-19

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  • The US FDA has extended by three months its review of the BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals
  • The decision comes after Regeneron submitted additional data from a prophylaxis trial. The FDA considers these additional data to be a Major Amendment to the BLA and has provided a new PDUFA date of July 13, 2022
  • The US FDA has not requested any new studies to complete its review of the current BLA at this time

Ref: Regeneron | Image: Regeneron

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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