Aug 28 (Reuters) – The U.S. Food and Drug Administration has approved a first-of-its-kind drug from Takeda Pharmaceutical and Protagonist Therapeutics to treat a rare blood cancer, the health regulator said on Friday.
The approval of rusfertide brings a highly anticipated, less-invasive treatment option for thousands of patients who have historically relied on frequent bloodletting procedures to manage their condition.
The companies were seeking approval for the drug to treat polycythemia vera, a rare, slow-growing blood cancer affecting roughly 90,000 Americans.
Rusfertide, branded as Mimrylo, will be made available to patients within 48 hours of FDA approval, Teresa Bitetti, president of Takeda’s global oncology business unit, told Reuters in an interview.
While the company did not disclose the exact list price of the drug at launch, Bitetti said the company would “price this in a way that is fair to the value, but then also ensures that there’s access for patients.”
Takeda is projecting peak global sales for the drug in the range of $1 billion to $2 billion.
The disease causes the bone marrow to produce too many red blood cells, thickening the blood and severely increasing the risk of life-threatening blood clots, strokes and heart attacks.
(Reporting by Kamal Choudhury, Mariam Sunny and Christy Santhosh in Bengaluru; Editing by Vijay Kishore)
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