On June 22, the NMPA official website showed that Takeda Pharmaceutical’s “Apadamtase alfa” has been approved for marketing in China for on-demand or prophylactic enzyme replacement therapy (ERT) in children and adults with congenital thrombotic thrombocytopenic purpura (cTTP) (Acceptance No.: JXSS2500043/4). This application had previously been granted priority review.
cTTP is an extremely rare chronic blood clotting disorder caused by a deficiency of the ADAMTS13 enzyme. Patients may experience thrombocytopenia, microangiopathic hemolytic anemia, multi-organ ischemic injury, and other symptoms. Without treatment, the mortality rate of acute TTP episodes exceeds 90%. Apadamtase alfa (TAK-755) is an enzyme replacement therapy developed by Takeda. This recombinant ADAMTS13 protein can replace the missing or dysfunctional ADAMTS13 enzyme, restore normal blood coagulation function, alleviate cTTP symptoms, and improve patients’ quality of life and life expectancy.
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