Accelerated Approval: Midodrine Experience Shows Regulatory Challenge US FDA Faces With Makena
Executive Summary
The orthostatic hypotension treatment midodrine has been on the market for more than 20 years despite the failure of postmarketing studies to confirm clinical benefit; an advisory committee soon will weigh the future of AMAG’s preterm birth drug Makena, which failed its confirmatory trial required as a condition of accelerated approval.
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Keep Makena Under Accelerated Approval Pending More Studies, AMAG Tells US FDA
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.
FDA Requests Withdrawal Of Makena And Generics
Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.
Accelerated Approval: US FDA Request For Makena’s Withdrawal Goes Beyond Failed Confirmatory Trial
Preterm birth prevention drug should come off the market to ensure the accelerated approval pathway does not operate as a lower approval standard, agency says; proposed withdrawal comes almost a year after an advisory committee split on the question of whether Makena should stay on the market in light of delayed, and ultimately unsuccessful, confirmatory study.
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