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

Executive Summary

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.

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Makena Hearing: Covis Seeks To Skip Question, Likely Negative Vote On Confirmatory Trial Results

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.

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

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.

Makena Withdrawal Hearing: US FDA Drugs Center, Covis Tussle Over Panel Composition

Practicing obstetricians who are maternal fetal-medicine specialists should make up a ‘significant proportion’ of the advisory committee at the forthcoming hearing, Covis says; CDER calls for a more ‘balanced’ panel that includes expertise in biostatistics, neonatology and epidemiology.

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