Ipsen: positive outcome of FDA Advisory Committee

 

• Advisory committee voted 10 for and 4 against that evidence from the Phase III MOVE study show palovarotene is an effective treatment in patients with the ultra-rare bone disease fibrodysplasia ossificans progressiva (FOP)
• Advisory committee further voted 11 for and 3 against on the benefits of palovarotene outweighing the risks, for the treatment of patients with FOP
• FDA PDUFA action date is anticipated by August 16, 2023

https://www.biospace.com/article/releases/ipsen-announces-positive-outcome-of-fda-advisory-committee-on-investigational-palovarotene-for-fibrodysplasia-ossificans-progressiva/