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Palovarotene FDA Approval Status

FDA Approved: No
Generic name: palovarotene
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Fibrodysplasia Ossificans Progressiva

Palovarotene is an oral, investigational, selective RARĪ³ agonist in development for the prevention of heterotopic ossification as a potential treatment option for people with fibrodysplasia ossificans progressiva (FOP).

Development timeline for palovarotene

DateArticle
Jun 29, 2022Ipsen Announces U.S. FDA Priority Review for Palovarotene New Drug Application in Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission
Aug 13, 2021Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses
May 28, 2021Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)
Oct 23, 2018Clementia Announces Plan to Submit a New Drug Application for Palovarotene for the Treatment of FOP Based on Positive Phase 2 Results
Apr 20, 2018Clementia Initiates Phase 2 MO-Ped Trial for Palovarotene in Patients with Multiple Osteochondromas
Dec 12, 2017Clementia Initiates Pivotal Phase 3 MOVE Trial for Palovarotene in Patients with Fibrodysplasia Ossificans Progressiva

Further information

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