Today the European Commission announced that they have determined NOT to grant marketing authorization approval for palovarotene as a treatment for fibrodysplasia ossificans progressiva (FOP). This decision follows the negative opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in May and means that palovarotene will not be made available to patients with FOP living in the European Union (EU).
You can read Ipsen's press release about the European Commission's decision here.
The press release does note that Ipsen continues seeking regulatory approvals in other countries and regions. In June 2023, the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food & Drug Administration (FDA) recommended that palovarotene be approved as a treatment for FOP.
We know that this news is very disappointing to many living with FOP in the European Union.
Palovarotene was studied in a comprehensive clinical program over 15 years and many of our European FOP families participated in the Natural History Study and the palovarotene trials. We are grateful for your selfless participation.
The European Commission's decision is also extremely disappointing to the team at Ipsen which is led by CEO David Loew who has written this letter to the FOP community.
If you live in an 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
If you have any additional questions, please send an email to [email protected]