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for Drug Evaluation and Research officials say accelerated approval of Covis’ preterm birth prevention drug should be withdrawn because substantial evidence of effectiveness no longer exists – separate from any concerns about study feasibility, off-label use or compounding.