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Makena Accelerated Approval Withdrawal Hearing Should Be In-Person, Covis Tells US FDA

Executive Summary

Covis cites challenges of conducting virtual meetings but leaves door open to hybrid approach. CDER wants advisory committee vote on feasibility of timely conducting new adequate, well-controlled trial, while Covis seeks vote on whether withdrawal is appropriate given absence of another approved drug for preventing preterm birth.

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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.

Accelerated Approval: Makena Real-World Evidence Insufficient To Verify Clinical Benefit, CDER Says

Covis seeks to discuss study proposals and other accelerated approval precedents at still-unscheduled withdrawal hearing; CDER says company’s current RWE proposal is inadequate given its design and the failure of the PROLONG confirmatory clinical trial.

US FDA’s Accelerated Approval Reforms Include Dispute Resolution For Withdrawals

Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.

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