FDA approved Ipsen’s Sohonos capsules for treatment of fibrodysplasia ossificans progressiva
Ipsen has announced that the US Food and Drug Administration (FDA) has approved Sohonos (palovarotene) capsules as a retinoid indicated for the reduction of new heterotopic ossification (HO) in adults as well as female paediatric patients over the age of eight and male paediatric patients over the age of ten with fibrodysplasia ossificans progressiva (FOP).
This approval is based on the safety and efficacy data from the phase 3 MOVE trial, data from which was published in the Journal of Bone and Mineral Research. The trial demonstrated that the drug effectively reduced annyalised HO volume compared to no treatment beyond standard of care. It also demonstrated the drug’s positive safety profile.
Howard Mayer, head of Research and Development at Ipsen, commented: “The FDA approval of Sohonos is a breakthrough for the US FOP community. For the first time doctors have an approved medicine available to them, shown to reduce the formation of new, abnormal bone growth, known as HO, which causes debilitating mobility challenges and has a devastating impact on the lives of people with FOP. Development of medicines for rare diseases takes commitment and belief from everyone involved. We at Ipsen are sincerely grateful to the FOP community of patients and medical experts, as the first-ever treatment in the US for managing FOP would not be possible without their participation in the clinical trials and ongoing support.”
Michelle Davis, executive director of International FOP Association, added: “FOP is life-altering to the individuals diagnosed and their families. There’s not a day that goes by where those impacted don’t worry about the debilitating physical pain of muscle that is replaced by bone, another joint locking or the relentless emotional toll of losing the ability to do an activity they love, or hold a loved one close. The first treatment for FOP has been proven to reduce the volume of new abnormal bone growth, which may result in better health outcomes for people living with FOP.”
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