Pharma Pulse: FDA Grants Priority Review to Rusfertide and Expands Approval for Novo Nordisk’s Sogroya

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• The FDA has granted priority review to rusfertide (Takeda Pharmaceuticals Inc) for the treatment of polycythemia vera. As a potential first-in-class hepcidin mimetic, this therapy regulates iron homeostasis to suppress excess red blood cell production, aiming to eliminate the need for frequent therapeutic phlebotomy. Phase III data showed that adding rusfertide to standard care more than doubled clinical response rates. A regulatory decision is anticipated in the third quarter of 2026.
• Additionally, the FDA has expanded approval for Novo Nordisk’s once-weekly Sogroya to include children aged two-and-a-half and older with three new pediatric growth disorders. This long-acting treatment replaces daily injections, offering over 300 injection-free days per year while maintaining efficacy that is non-inferior to daily regimens. Looking ahead, a supplemental application for Turner syndrome is currently under review, with a decision expected later this year.

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