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A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)

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Trial Profile

A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2023

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At a glance

  • Drugs Hydrocortisone (Primary) ; Lidocaine/prilocaine (Primary) ; Palovarotene (Primary)
  • Indications Fibrodysplasia ossificans progressiva
  • Focus Registrational; Therapeutic Use
  • Acronyms MOVE
  • Sponsors Clementia Pharmaceuticals

Most Recent Events

  • 16 Aug 2023 According to Ipsen media release, the company announced an approval by the U.S. Food and Drug Administration (FDA) of Sohonos™ (palovarotene) capsules as a retinoid indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). The approval is based on the results from this study.
  • 29 Jun 2023 According to Ipsen media release, based on this trial the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP).
  • 16 Mar 2023 According to Ipsen media release, company receives new FDA PDUFA date (16 August 2023) for investigational palovarotene.

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