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Update as of 7 February 2023:
The applicant for Sohonos has requested a re-examination of EMA’s January 2023 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its recommendation and issue a final recommendation.

The European Medicines Agency has recommended the refusal of the marketing authorisation for Sohonos, a medicine intended for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is a rare genetic disease that causes extra bone to form in places outside the skeleton (a process called heterotopic ossification) such as in joints, muscles, tendons and ligaments, leading to progressively decreasing mobility and other severe impairments.

The Agency issued its opinion on 26 January 2023.  The company that applied for the authorisation, Ipsen Pharma, may ask for re-examination of the opinion within 15 days of receiving the opinion.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • palovarotene
Active substance
  • Palovarotene
Therapeutic area
Myositis Ossificans

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
Company name
Ipsen Pharma
Application type
Initial authorisation

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