Ipsen's Sohonos Scores Canadian Approval For Rare Connective Tissue Disease

Health Canada has approved Ipsen SA's IPSEY Sohonos (palovarotene capsules) in adults and children aged eight years & above for fibrodysplasia ossificans progressiva (FOP).

• This decision marks the first approval for Sohonos worldwide.
• Sohonos is an oral selective retinoic-acid receptor gamma (RARγ) agonist indicated to reduce the formation of heterotopic ossification (HO; new bone formation) to treat FOP. 
• FOP is characterized by new bone formation outside of the normal skeletal system, like in soft connective tissues, in a process is known as heterotopic ossification, which can be preceded by painful soft tissue swelling or "flare-ups." 
• Ipsen plans to file in the U.S. in H1 2022 and is in discussions with other regulatory authorities worldwide.
• This approval is based on the ongoing MOVE Phase 3 trial data.
• The trial is evaluating the efficacy and safety of a chronic/flare-up dosing regimen of palovarotene in decreasing new annualized HO volume in patients with FOP.
• Price Action: IPSEY shares closed at $23.66 on Friday.