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# Takeda Priority BLA for Clotting Disorder
- URL: https://www.fdaweb.com/takeda-priority-bla-for-clotting-disorder/
- Published: 2023-05-17T12:00:00.000Z
- Updated: 2026-09-14T18:32:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154477

FDA has accepted for priority review a Takeda BLA for TAK-755, an enzyme replacement therapy for treating congenital thrombotic thrombocytopenic purpura, an ADAMTS13 deficiency disorder. The ultra-rare clotting disorder is caused by a deficiency in ADAMTS13 protease, the company says, adding that the mortality rate, if left untreated, is greater than 90%. Currently, there are no therapies specifically approved for prophylactic treatment, it says.

The BLA is based on data from a Phase 3 trial designed to evaluate the clinical benefit of TAK-755 across multiple clinically relevant endpoints, compared to plasma-based therapies. Interim results show that TAK-755 reduced the incidence of thrombocytopenia events by 60% compared to plasma-based therapy, Takeda says. “The proportion of subjects experiencing adverse events determined to be related to the treatment was substantially lower among subjects during treatment with TAK-755 (8.9%) compared to plasma-based therapies (47.7%),” it adds.