Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP
- PDUFA date has been set for 16 August 2023 following the New Drug Application resubmission containing additional information on palovarotene clinical trial data, requested in a complete response letter to Ipsen in December 2022
PARIS, FRANCE, 16 March 2023 – Ipsen (IPNIPSEY today 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, 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.1,2
Data submitted to the FDA include additional analyses from across the palovarotene clinical trial program, including the pivotal MOVE study,3 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.
Palovarotene is authorized 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.
ENDS
About FOP
FOP impacts the lives of an estimated 900 people globally.1,2 The disease continuously progresses with flare-up episodes causing rapid bone growth. Most people living with FOP inevitably lose the ability to eat and drink on their own, cannot…
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