Makena Panel Vote Adversely Influenced By Framing Of Withdrawal Question, Covis Says
‘Ad hoc narrowing’ of the final voting question by hearing officer Celia Witten prevented adcomm members from voting on Covis’ proposal to restrict the preterm birth prevention drug's indication while further study was conducted, company says.
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End Of An Accelerated Approval Odyssey: Covis Agrees To Withdraw Makena But Seeks 21-Week ‘Wind-Down’
Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.
US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close
Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.
The Makena Deciders: FDA Commissioner Califf, Chief Scientist Bumpus To Jointly Make Final Call On Drug’s Fate
The two senior agency officials will render the decision together as co-signatories on whether Makena loses its accelerated approval or is allowed to stay on the market; that decision will not come before mid-January, and is likely to be weeks or months later, based on a timeline set out by hearing officer Celia Witten.