As you may remember, in January 2023 the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) reviewed Ipsen's investigational drug palovarotene and recommended the EMA NOT grant marketing authorization (i.e. approval) for palovarotene as a treatment for fibrodysplasia ossificans progressiva (FOP). You can read that press release here.
Ipsen requested a re-examination and, today, they have released the results of that review: confirmation of the "Negative Opinion" given in January 2023. The final decision will be given by the European Commission (EC) in a couple of months’ time, but negative opinions of the CHMP have never been reversed. If you live in a European Union (EU) country and have questions about your participation in the PIVOINE Rollover Study as well as the availability of other FOP clinical trials, please consult your doctor. The IFOPA has a full list of available clinical trials at ifopa.org/ongoing_clinical_trials_in_fop
We know that this news is very disappointing to many in the FOP community, including trial participants and principal investigators. You will see a comment on that in the press release. It is also extremely disappointing to the team at Ipsen which is led by CEO David Loew who has written this letter to be shared with the FOP community.
This news from the EU comes just one day after the IFOPA announced that the U.S. Food & Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee will review palovarotene as a potential treatment for FOP on June 28, 2023. Unlike the EU's CHMP, the FDA invites FOP community members to electronically submit written comments and photos which the Committee will receive as part of their preparation materials for the meeting. This written comment opportunity is open to all members of the FOP community worldwide, not just U.S. residents, but all letters must be submitted in English by June 14, 2023. Learn more and get the link to submit your letter.
Thank you again to all of those living with FOP who participated in the MOVE trial, as well as their dedicated families who supported them during the process. If you have any questions, please send an email to [email protected]