Health Canada approves Ipsen’s Sohonos™ (palovarotene capsules) as the first approved treatment for progressive fibrodysplasia ossificans

PARIS, January 24, 2022–(BUSINESS WIRE)–Regulatory news:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced Health Canada’s approval of Sohonos (palovarotene capsules), a selective oral retinoic acid receptor gamma (RARγ) agonist indicated to reduce the formation of heterotopic ossification (HO; new bone formation) in adults and children aged 8 years and older for women and 10 years and older for men with fibrodysplasia ossificans progressiva (FOP).1 Sohonos is approved for the treatment of patients with FOP for both chronic use and for flare-ups in these patient populations. This decision marks the first approval of Sohonos in the world.

Dr Howard Mayer, Executive Vice President and Head of Research and Development, Ipsen, said, “FOP is a progressive and debilitating disease that has such a profound impact on patients and their families. Until today, there were no approved drugs, and we are proud to bring this important new drug to the FOP community.

FOP is characterized by new bone formation outside of the normal skeletal system, such as in the soft connective tissues, a process known as heterotopic ossification,2 which may be preceded by painful soft tissue swelling or “flare-ups”.2 Pushing episodes are common and contribute substantially to the formation of new bone, but bone can also form in the absence of pushing. Once formed, it is irreversible and leads to loss of mobility and shortened life expectancy.2 It is an ultra-rare genetic disease with an estimated prevalence of 1.36 per million individuals; however, the number of confirmed cases varies by country.3.4.

As part of its continued commitment to the FOP and rare disease community, Ipsen expects to file an application in the United States in the first half of 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 world’s first multicenter Phase III FOP trial. MOVE is a single-arm, open-label trial evaluating the efficacy and safety of a chronic/flare dosing regimen of palovarotene to reduce 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 ultra-rare debilitating genetic disease, FOP. The treatment was acquired by Ipsen through the acquisition of Clementia Pharmaceuticals in April 2019. It is part of the class of retinoid drugs associated with birth defects in humans. Sohonos should not be used by patients who are or intend to become pregnant due to the risk of teratogenicity. To minimize fetal exposure, Sohonos should only be administered if all conditions for pregnancy prevention are met. Sohonos has been shown to cause premature physisal closure in growing children with FOP; periodic monitoring is recommended.

About Ipsen
Ipsen is a mid-market international biopharmaceutical company specializing in transformative medicines in oncology, rare diseases and neurosciences; it also has a well-established Consumer Healthcare business. With total sales of more than €2.5 billion in fiscal year 2020, Ipsen markets more than 20 medicines in more than 115 countries, with a direct commercial presence in more than 30 countries. The Company’s research and development efforts focus on its innovative and differentiating technological platforms located at the heart of major biotechnology and life sciences hubs: Paris-Saclay, France; Oxford, UK; Cambridge, USA; Shanghai, China. Ipsen has approximately 5,700 employees worldwide and is listed in Paris (Euronext: IPN) and in the United States via a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

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1 Data on file
2 Kaplan FS, et al. The medical management of fibrodysplasia ossificans progressiva: current therapeutic considerations. Proc Intl Clin Council FOP 1:1-111, 2019.
3 Lilijestrom, M & Bogard, B 2016, “The World Population Known for FOP”, FOP Drug Development Forum, Boston, MA, October 24-25.
4 Baujat et al. Prevalence of fibrodysplasia ossificans progressiva (FOP) in France: an estimate based on a linkage of records from two national databases. Orphanet review of rare diseases. 2017; 12:123.

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