French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its first-in-class drug Altuviiio (Fc-VWF-XTEN fusion protein). This new treatment is indicated for controlling the bleeding tendency in patients with hemophilia A, a genetic disorder that impairs the body’s ability to clot blood.
Phase III Study Results and Approval Basis
The decision by the MHLW was based on data from a Phase III study that demonstrated the efficacy of Altuviiio. The once-weekly injection provided mean factor VIII activity greater than 40% for most of the week, a significant threshold for patients with hemophilia A. This treatment helps reduce the annualized bleeding rate (ABR) and prevent joint bleeds, which are common complications associated with the condition.
Global Market Expansion for Altuviiio
Altuviiio has recently made its way into the markets of Taiwan and the US, marking a significant expansion for this novel therapy. The drug’s approval in Japan further broadens its global reach, offering a new treatment option for patients with hemophilia A and highlighting Sanofi’s commitment to addressing unmet medical needs in the field of bleeding disorders.-Fineline Info & Tech
