Makena Sponsor Covis Seeks To Use FDA Officials’ Words, Actions On Accelerated Approval Against CDER
Company cites comments by Oncology Center of Excellence Director Richard Pazdur and Office of Neuroscience Director Billy Dunn on reasons why confirmatory trials fail and the need for regulatory flexibility. Ironically, both senior officials have publicly extracted commitments from companies to withdraw products if postmarketing trials do not verify clinical benefit.
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Failed Confirmatory Trial Won’t Force Withdrawal Of Zepzelca’s Accelerated Approval, US FDA Says
Jazz/PharmaMar’s SCLC drug will stay on the market while two more trials with different designs are conducted after confirmatory trial did not meet overall survival endpoint. Citizen petition requesting agency withdraw lurbinectedin underscores vagaries of accelerated approval.
FDA’s Peter Stein And Lessons From Makena: There Are Limits To Regulatory Flexibility
Office of New Drug head said agency was willing to apply regulatory flexibility when it granted Makena its initial accelerated approval but says to give the drug the type of flexibility sponsor Covis wants now would set a ‘troubling’ precedent.
Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing
The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.