Favorable FDA AdCom vote for Ipsen

The US Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor of investigational palovarotene as an effective treatment, with a positive risk-benefit profile, for people living with the ultra-rare bone disease, fibrodysplasia ossificans progressiva (FOP).

Palovarotene is under development by French mid-sized drugmaker Ipsen (Euronext: IPN), whose shares were up 3.8% at 110.20 euros by late morning today. This is good news for the firm, which received a complete response letter from the FDA late last year, in response to the company’s second submission.

The FDA is currently reviewing the New Drug Application (NDA) for palovarotene with a decision anticipated by August 16, 2023. If approved, palovarotene will be the first treatment in the USA for FOP.