Susoctocog alfa filed in Japan for the control of bleeding episodes in patients with acquired hemophilia A (AHA)
Takeda Pharmaceutical on June 30 filed a new drug application in Japan for its recombinant, porcine sequence factor VIII susoctocog alfa for the control of bleeding episodes in patients with acquired hemophilia A (AHA)
AHA is a rare life-threatening bleeding disorder caused by autoantibodies (inhibitors) against human coagulation factor VIII that typically affects older adults. The submission is based on the results of a PII/III study, NCT04580407, which enrolled Japanese adults with AHA as well as an overseas PII/III trial targeting non-Japanese adults with AHA, NCT01968655. Both studies investigated the safety and efficacy of susoctocog alfa. The drug is approved outside Japan under the trade name of Obizur.
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