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Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing

Executive Summary

The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.

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N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

Makena: New Randomized Trial May Only Happen If Drug Stays On The US Market

Covis declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.

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