Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug Application (NDA) filing for its Obizur (susoctocog alfa) has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for use as an on-demand treatment and prevention of bleeding in adult patients with acquired hemophilia A (AHA).
Drug Background and Mechanism
Obizur, the first recombinant porcine FVIII (RPF VIII) drug approved in the US and Europe for acquired hemophilia A, is designed to provide a new treatment option for Chinese patients with this rare and serious bleeding disorder. AHA is characterized by the presence of anti-coagulation factor VIII autoantibodies in circulating blood, leading to decreased FVIII activity and a high risk of spontaneous or abnormal bleeding.
Clinical Trial Results
A prospective, multicenter, open Phase II/III study included 28 patients with AHA. The results showed that 100% of patients had an evaluable response (bleeding stopped or decreased) within 24 hours of administration. As a recombinant protein, Obizur reduces the risk of transmission of blood-borne pathogens.-Fineline Info & Tech
