TOKYO (dpa-AFX) - The U.S. Food and Drug Administration approved Takeda Pharmaceutical's (TAK, TKPHF, 4502.T) Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to produce too many red blood cells. The excess cells can thicken the blood and increase the risk of cardiovascular complications, including blood clots, stroke, and heart attack.
Mimrylo introduces a novel treatment approach for patients whose disease has not been adequately controlled with existing therapies. It is the first approved therapy for polycythemia vera that mimics hepcidin, a hormone that naturally regulates iron in the body. By limiting the iron available to produce new red blood cells, Mimrylo helps reduce their overproduction and maintain healthier red blood cell levels.
Takeda noted that the open-label extension of the VERIFY trial is ongoing, and the company will share further findings at upcoming medical conferences. In addition, the company is working with regulators outside of the U.S. to potentially make Mimrylo available to more patients worldwide.
The approval does not affect its consolidated financial forecast for the fiscal year ending March 31, 2027, the company said.
TAK closed Friday's regular trading at $18.03, unchanged on the day. In after-hours trading, the stock rose to $18.49, gaining $0.46 or 2.53%.
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