Regeneron Reports the US FDA’s Acceptance of Priority Review for REGEN-COV for the Treatment and Prophylaxis of COVID-19

Shots:

• The US FDA has accepted for priority review a BLA for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals
• The BLA is based on P-III study assessing efficacy & safety of REGEN-COV to treat non-hospitalized patients already infected with SARS-CoV-2, and to prevent symptomatic infection in asymptomatic household contacts of SARS-CoV-2 infected individuals
• The second BLA submission focused on the treatment of patients hospitalized due to COVID-19 and is expected to be submitted later this year. The FDA has assigned a PDUFA date of Apr 13, 2022 and is currently planning to hold an advisory committee meeting to discuss this application in advance of that date

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