Ipsen (OTCPK:IPSEY) announces the Health Canada approval of Sohonos (palovarotene capsules), an oral selective 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 above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (FOP).
FOP is a progressive and debilitating condition, characterized by new bone formation outside of the normal skeletal system, like in soft connective tissues, which can be preceded by painful soft tissue swelling or “flare-ups.”
This approval is based on data from the ongoing MOVE 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.
This decision marks the first approval for Sohonos worldwide. Ipsen plans to file in U.S. in H1 2022 and is in discussions with other regulatory authorities around the world.