Acquired Hemophilia a Bleeding Treatment 'OBIZUR' Approved in Korea

On March 20, Takeda's OBIZUR (component name: susoctogog alfa), a bleeding treatment for adult acquired hemophilia A, was approved in Korea by the Ministry of Food and Drug Safety.

Acquired hemophilia A (AHA) is a disease in which autoimmune antibodies to blood clotting factors 8 occur and bleeding-related complications occur. It rarely occurs in 1 out of every 1 million people a year, but it tends to bleed more fatal than congenital hemophilia A patients.

Unlike conventional bypass factor drugs, OBIZUR is a treatment that replaces blood coagulation factor 8 with AHA adaptation, and is a gene recombinant drug made by removing B-domain from pig blood coagulation factor 8 similar to humans. Since it is not easily recognized by autoimmune antibodies, it can replace inactivated human blood coagulation factor 8 to help blood coagulation and control bleeding.

As a result of an open-label 2/3 study evaluating the effectiveness of OBIZUR in 28 patients with acquired hemophilia A, all patients treated with OBIZUR showed a positive response to all initial bleeding episodes at 24-hour evaluation after the first administration. Positive response refers to cases where bleeding is stopped or reduced, there is a clinical improvement, or blood coagulation factor 8 activity is above the target.

The treatment success rate within 2 weeks of administration was 85.7% (24/28 patients), and the treatment success rate was higher in the patient group who used OBIZUR as the primary treatment. The success rate of treatment in the patient group who received OBIZUR in the first treatment was 94% (16/17) and the success rate in the second treatment was 73% (8/11). There were no serious abnormalities or deaths related to OBIZUR.