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Ipsen Announces New FDA PDUFA Date for Investigational Palovarotene

Friday, March 17, 2023

Ipsen announced that the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date, for the resubmitted New Drug Application (NDA) for investigational 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, will be the first treatment for an estimated 400 people in the U.S. living with FOP, an ultra-rare, progressive, life-limiting bone disease.

Palovarotene is authorised for use in appropriate patients in Canada where it is marketed as SohonosTM (palovarotene capsules). It also has conditional approval in United Arab Emirates. Investigational palovarotene is under review with several regulatory authorities.

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