FDA Clears Ipsen’s Sohonos

Image Credit: Adobe Stock Images/Nokers13

In a company press release, Ipsen revealed the FDA approval of Sohonos (palovarotene), indicated for the reduction in volume of new heterotopic ossification in adults and pediatric patients aged 8 years and older for females and 10 years and older for males with fibrodysplasia ossificans progressiva (FOP). Based on efficient data from the medicine’s phase three trial, results determined palovarotene effectively reduced annualized heterotopic ossification volume compared with no treatment beyond standard of care.

“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,” said Michelle Davis, executive director of International FOP Association, according to the release. “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.”

Reference:

US FDA approves Ipsen’s Sohonos™ (palovarotene) capsules, the first and only treatment for people with fibrodysplasia ossificans progressiva. August 16, 2023. Accessed August 18, 2023. https://www.ipsen.com/press-releases/us-fda-approves-ipsens-sohonostm-palovarotene-capsules-the-first-and-only-treatment-for-people-with-fibrodysplasia-ossificans-progressiva/