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  • FDA issue PDUFA date after palovarotene is refiled...

FDA issue PDUFA date after palovarotene is refiled to treat fibrodysplasia ossificans progressiva.- Ipsen

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Published:17th Mar 2023

Ipsen announced that the FDA Prescription Drug User Fee Act (PDUFA) goal date, for the resubmitted New Drug Application (NDA) for investigational Sohonos (palovarotene) as a potential treatment for fibrodysplasia ossificans progressiva (FOP), is 16 August 2023.

Additional information on palovarotene clinical trial data, requested in a complete response letter to Ipsen in December 2022, will be reviewed as part of this resubmission process. If approved, palovarotene, which has received FDA Breakthrough Therapy and Orphan Drug designations, would be the first treatment for an estimated 400 people in the U.S. living with FOP, an ultra-rare, progressive, life-limiting bone disease.

Data submitted to the FDA include additional analyses from across the palovarotene clinical trial program, including the pivotal MOVE study the first Phase III study carried out in people with FOP. Furthermore, Ipsen has requested a re-examination of the European Medicines Agency’s January 2023 Committee for Medicinal Products for Human Use (CHMP) opinion on palovarotene.

Condition: Fibrodysplasia Ossificans Progressiva
Type: drug

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