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
