Takeda's Mimrylo Gets FDA Approval to Treat Blood Cancer Condition
By Elias Schisgall
Takeda's treatment for erythrocytosis in adults with polycythemia vera, a form of blood cancer, received approval from the Food and Drug Administration.
The company said Friday that the FDA approved its new drug application for Mimrylo, also known as rusfertide. The drug treats adults with erythrocytosis who have PV, a condition involving an abnormally high concentration of red blood cells.
"The approval of Mimrylo underscores the strength of Takeda's late-stage pipeline and our focus on developing genuinely differentiated therapies for patients who are urgently waiting for new options," Chief Executive Julie Kim said.
The development does not impact Takeda's guidance for the current fiscal year, the company said.
The agency's approval was based on data from the company's Phase 3 trial of the treatment. An open-label extension of that trial is continuing, and the company said it is engaging with international regulators about the drug.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
August 28, 2026 19:17 ET (23:17 GMT)
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