FDA Panel Votes In Favor Of Ipsen's Palovarotene For Ultra-rare Bone Disease

(RTTNews) - Ipsen (IPSEY) said that the U.S. Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of investigational palovarotene as an effective treatment for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva.

The FDA is currently reviewing the New Drug Application for palovarotene with a decision anticipated by August 16, 2023. If approved, palovarotene will be the first treatment in the U.S. for fibrodysplasia ossificans progressiva.

The 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. The committee further voted 11 for and 3 against on the benefits of palovarotene outweighing the risks, for the treatment of patients with fibrodysplasia ossificans progressiva.

Fibrodysplasia ossificans progressiva or FOP is an ultra-rare disease that causes permanent and continuous bone growth in soft and connective tissues like muscles, tendons and ligaments, also known as heterotopic ossification. FOP impacts the lives of an estimated 400 people in the U.S. and 900 people globally.

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