Makena Accelerated Approval Hearing Will Be Virtual, Likely In September Or October
Presiding officer Celia Witten denies Covis’ request for an in-person hearing, saying it is unclear at this time how COVID would affect a proceeding in the fall. Hearing agenda spans two-and-a-half days and is modeled, in part, on the Avastin hearing, but with twice the time for public comment.
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By proposing to stipulate that findings from the PROLONG study do not verify Makena’s clinical benefit on neonatal morbidity and mortality from complications of preterm birth, Covis could avoid what would likely be a highly negative vote on the first question posed to the advisory committee at the 17-19 October public hearing on withdrawal of the application.
The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.
Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.