Health Canada Approves Ipsen’s Sohonos (palovarotene) as the First Approved Treatment for Fibrodysplasia Ossificans Progressiva (FOP)
On Jan 24, Ipsen announced the Canada approval of Sohonos (palovarotene capsules). Indicated to reduce new bone formation in adults and children (8 years and above for females and 10 years and above for males) with FOP. Sohonos is approved for both chronic use, and for flare-ups. It is the first approval for Sohonos worldwide.
FOP is a progressive and debilitating condition which has such a profound impact on patients, and their families. Until today, there was no approved medicine, and we are proud to bring this important new medicine to the FOP communityDr. Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen
About the MOVE clinical program
This approval is based on data from the MOVE trial. The first global multi-center Phase III trial in FOP. MOVE is an open-label, single-arm trial, evaluating the efficacy and safety of palovarotene in decreasing new ossification volume in patients with FOP.
Sohonos is an oral, selective RARγ agonist developed as a treatment for people living with this debilitating ultra-rare genetic disorder. The treatment was acquired by Ipsen through the acquisition of Clementia Pharmaceuticals.
Ipsen is a global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience; For more information, visit ipsen.com.
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