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 for Sohonos worldwide.
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 RAR 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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