FDA adcomm votes in favor of Ipsen's fibrodysplasia drug
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted in support of the efficacy and risk-benefit profile of Ipsen Biopharmaceuticals’ drug palovarotene, which the agency is reviewing for the treatment of the ultra-rare disease fibrodysplasia ossificans progressiva.
While FDA staff had raised concerns about the drug’s safety and efficacy, the panel of outside advisors voted 10-4 that evidence from a Phase III study showed the drug was effective, and 11-3 that the benefits of the drug outweighed its risks.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.
