On August 16, 2023, Ipsen received approval from the U.S. Food & Drug Administration for palovarotene capsules as a treatment for FOP in females aged 8 and up and males aged 10 and up living in the United States. It was approved by Health Canada with the same label in January 2022. Where approved as a treatment for FOP, palovarotene capsules are now known by the brand name SohonosTM.
The International Clinical Council (ICC) on FOP has issued this statement on palovarotene
The ICC is an international collaboration of 21 clinicians worldwide with expertise in the care of patients with FOP. The ICC seeks to consolidate and coordinate clinical knowledge and advice on clinical care, symptomatic treatment, and clinical trial development into a framework that best serves the needs of FOP patient community worldwide. Details and current membership of the ICC can be found at iccfop.org. Individuals on the ICC may have roles as volunteer or paid advisors, consultants, or research investigators affiliated with pharmaceutical companies. These disclosures are available on request. Statements credited to an individual reflect the opinion of that person, and do not reflect the opinion of the ICC.
The IFOPA is grateful to the ICC on FOP for their service to the community.
