Pharmaceutical News Update

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Although FOP is an ultra-rare genetic condition, we are fortunate to have a number of pharmaecutial companies who are actively researching into a treatment and a cure for FOP.

We are thankful to everyone who is working towards a treatment and a cure for those living with FOP.

OPTIMA Phase 3 Trial Update

Regeneron’s Phase 3 OPTIMA trial for garetosmab showed highly positive results, with up to a 99% reduction in abnormal bone formation in adults with FOP. Following these promising results, Regeneron plans to seek US marketing approval from the FDA by the end of 2025. Submissions for other regions, including the UK, and a trial for children will follow, but the full data is still undergoing regulatory review.

Trustee Dr Andrew Rankin has written a summary of the report here: OPTIMA Summary September 2025

For the full press release, visit: Regeneron

SOHONOS by Ipsen

Sohonos (palovarotene) isthe first treatment developed to reduce new abnormal bone formation in FOP. It has been approved for FOP in Canada (since January 2022), the US (since August 2023) and Australia (November 2023).  In the EU/UK it is not approved for the treament of FOP, because regulators judged the evidence and safety-profile did not meet their requirements. For people in the UK with FOP, this means the drug is not yet an authorised routine treatment option.

You can read more here: Sohonas: a summary

Visit the Sohonos website: https://www.sohonos.com/for-patients