Pharma Focus Asia

Takeda Announces U.S. FDA Acceptance of Biologics Licence Application (BLA) for TAK-755

Wednesday, May 17, 2023

Takeda announced that the U.S. Food and Drug Administration (FDA) has accepted Biologics Licence Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder.

TAK-755 is the first and only recombinant ADAMTS13 protein in development. It provides targeted therapy to address an unmet medical need in patients with thrombotic thrombocytopenic purpura (TTP), by replacing the missing or deficient ADAMTS13 enzyme

There is a critical need for treatment options for people living with cTTP, an ultra-rare, life-threatening disorder that has no therapies specifically approved for prophylactic treatment. If approved, TAK-755 will be the first and only recombinant ADAMTS13 (rADAMTS13) replacement therapy for cTTP, a disorder with considerable unmet patient need.

cTTP is an ultra-rare inherited form of thrombotic thrombocytopenic purpura (TTP), a chronic and debilitating clotting disorder caused by a deficiency in ADAMTS13 protease. Acute TTP has a mortality rate of >90 percent, if left untreated.

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