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.
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