Makena’s Accelerated Approval Will Hang In Balance At US FDA Panel Meeting In October

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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Whether Makena should continue to be marketed for preventing preterm birth is the focus of an October AdComm. • Source: Shutterstock

For the first time since 2011, a US Food and Drug Administration advisory committee will consider whether an accelerated approval drug should continue to be marketed given the failure of a postmarketing trial to verify clinical benefit.

On 29 October, the agency’s Bone, Reproductive and Urologic Drugs Advisory Committee will re-evaluate the regulatory status of AMAG...

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