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

  | Ref: Regeneron | Image: WRGB