FDA ACCEPTS REGEN-COV® (CASIRIVIMAB AND IMDEVIMAB) FOR PRIORITY REVIEW FOR TREATMENT AND PROPHYLAXIS OF COVID-19https://investor.regeneron.com/news-releases/news-release-details/fda-accepts-regen-covr-casirivimab-and-imdevimab-priority-reviewTARRYTOWN, N.Y., Oct. 14, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a 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 FDA has assigned a target action date of April 13, 2022 and informed us that they currently are planning to hold an advisory committee meeting to discuss this application in advance of that date.
The BLA is supported by two positive Phase 3 trials involving more than 6,000 patients that evaluated the efficacy and 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 (both uninfected and infected contacts). A second BLA submission focusing on the treatment of patients hospitalized due to COVID-19 is expected to be submitted later this year.
REGEN-COV has been used for 10 or 11 months under an EUA that has been broadened to include more stages of infection than the original authorized group. I do not get why the decision date is as far out as April 13, 2022! How is a 6 month delay "priority review"? Are they teaching the reviewers how to read so they can then review the trials data?
