Health Canada Approves Ipsen’s Sohonos™ (palovarotene capsules) as the First Approved Treatment for Fibrodysplasia Ossificans Progressiva
Ipsen has received Health Canada approval for Sohonos (palovarotene capsules), the first treatment for fibrodysplasia ossificans progressiva (FOP), enabling chronic use and flare-up management for patients aged 8 and above. This marks Sohonos' first global approval, following the MOVE trial which evaluated its efficacy in reducing new bone formation. Ipsen plans to file for U.S. approval in H1 2022 and is in discussions with other global regulators. FOP is an ultra-rare genetic disorder affecting 1.36 per million individuals.
- Health Canada approval for Sohonos as the first treatment for FOP.
- Potential for new revenue from the FOP treatment market.
- Plans to file for approval in the U.S. may expand market access.
- Sohonos poses teratogenic risks, limiting its use in women of childbearing age.
- FOP is an ultra-rare condition, which may restrict patient population and revenue potential.
Dr.
FOP is characterized by new bone formation outside of the normal skeletal system, like in soft connective tissues, a process known as heterotopic ossification,2 which can be preceded by painful soft tissue swelling or “flare-ups.”2 Flare-up episodes are common and are a substantial contributor to the formation of new bone, however bone can also form in the absence of a flare-up. Once formed, it is irreversible and leads to loss of mobility and shortened life expectancy.2 It is an ultra-rare genetic disorder with an estimated prevalence of 1.36 per million individuals; however, the number of confirmed cases varies by country.3,4.
As part of the ongoing commitment to the FOP and rare disease community, Ipsen plans to file in the US in H1 2022 and is in discussions with other regulatory authorities around the world.
About the MOVE clinical program
This approval is based on data from the ongoing 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 a chronic/flare-up dosing regimen of palovarotene in decreasing new annualized HO volume in patients with FOP
About Sohonos Sohonos is an oral, selective RARγ agonist developed as a treatment for people living with the debilitating ultra-rare genetic disorder, FOP. The treatment was acquired by Ipsen through the acquisition of
About Ipsen
Ipsen is a global, mid-sized biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease and Neuroscience; it also has a well-established
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1 Data on file
2 Kaplan FS, et al. The medical management of fibrodysplasia ossificans progressiva: current treatment considerations. Proc Intl Clin Council FOP 1:1-111, 2019.
3 Lilijesthrom, M & Bogard, B 2016, ‘The global known FOP population’,
4 Baujat et al. Prevalence of fibrodysplasia ossificans progressiva (FOP) in
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