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US Accelerated Approval: As Makena Withdrawal Hearing Looms, A Look Back At The Avastin Experience

Executive Summary

With the public hearing on Covis’ drug for preterm birth prevention expected in 2022, the Pink Sheet talked to several former FDA officials and advisory committee members about their experiences at the 2011 hearing on withdrawal of Avastin’s accelerated approval for breast cancer.

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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.

Effectiveness Or Bust: Without Benefit, No Case For Keeping Makena On The Market, CDER Says

FDA Center for Drug Evaluation and Research officials say accelerated approval of Covis’ preterm birth prevention drug should be withdrawn because substantial evidence of effectiveness no longer exists – separate from any concerns about study feasibility, off-label use or compounding.

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