(News Bulletin 247) – Ipsen announced today that the US regulatory authorities (FDA) have communicated a new date under the Prescription Drug User Fee Act (PDUFA), August 16, 2023, to respond to the new request for approval of investigational palovarotene as a potential treatment for fibrodysplasia ossificans progressiva (FOP).
Additional information regarding clinical trial data on palovarotene, requested in a full response letter to Ipsen in December 2022, will be considered as part of the new submission process.
If approved, palovarotene, which has been granted orphan drug status and ‘Breakthrough Therapy’ designation by the FDA, will be the first treatment for nearly 400 people in the United States with FOP, the ultra- rare and progressive which limits life expectancy.
Ipsen has further requested the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency to reconsider its position on palovarotene communicated in January 2023.
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