Takeda (TAK) Receives FDA Priority Review for Rusfertide in PV Treatment

Takeda Pharmaceutical Company Limited (NYSE:TAK) is one of the best future stocks to buy for the next 5 years. On March 2, Takeda and Protagonist Therapeutics announced that the US FDA accepted the NDA and granted Priority Review for rusfertide. An investigational, first-in-class hepcidin mimetic peptide, rusfertide is intended for the treatment of adults with polycythemia vera/PV. The FDA established a Prescription Drug User Fee Act target action date within Q3 2026. This milestone follows previous Breakthrough Therapy, Orphan Drug, and Fast Track designations granted to the therapeutic.

The regulatory submission is primarily supported by results from the Phase 3 VERIFY study and long-term data from the Phase 2 REVIVE and THRIVE studies. In the VERIFY trial, rusfertide combined with standard of care more than doubled clinical response rates compared to standard care alone. Patients experienced improvements in hematocrit control, a reduction in the need for phlebotomy, and improved patient-reported outcomes regarding fatigue and symptom burden.

Takeda Pharmaceutical Company Limited (NYSE:TAK) and Protagonist entered a worldwide license and collaboration agreement for rusfertide in January 2024. Under this partnership, Protagonist led the development through Phase 3, while Takeda is responsible for the US regulatory strategy and future global filings.

Takeda Pharmaceutical Company Limited (NYSE:TAK) is a healthcare company that develops pharmaceutical products for gastroenterology, rare diseases, plasma-derived therapies, immunology, oncology, and neuroscience.

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