Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October
Executive Summary
Advisory committee will re-evaluate the continued marketing of AMAG Pharmaceuticals’ preterm birth drug after a failed confirmatory study; the last time an advisory committee weighed in on the future of an accelerated approval drug was for Avastin's breast cancer claim.
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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.