FDA Advisory Committee Recommends Ipsen's Palovarotene as an Effective and Safe...

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• 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

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