After re-examining its initial opinion, the European Medicines Agency has confirmed its recommendation to refuse 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 after re-examination on 25 May 2023. The Agency had issued its initial opinion on 26 January 2023. The company that applied for authorisation of Sohonos, Ipsen Pharma, had requested a re-examination of EMA’s initial opinion.
Questions and answers on the refusal of the marketing authorisation for Sohonos (palovarotene) (PDF/97.81 KB)Adopted
First published: 27/01/2023
Last updated: 27/07/2023
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