Baxalta Inc (NYSE:BXLT) reports an expansion of its footprint in Japan after the Ministry of Health, Labour and Welfare in Japan gave the nod to the marketing of its ADYNOVATE in the region. The company’s drug, also known as Antihemophilic Factor (Recombinant), is developed for the treatment of hemophilia A patients aged 12 years or more.
Use of proven technology
ADYNOVATE is built around ADVATE, which is a well-known treatment for hemophilia A and boasts of 12 years of patient experience. The therapy involved a proprietary technology that extends the time of FVIII availability in the blood. Also, the technology increased circulating half-life by cutting the speed at which ADYNOVATE is expelled from the blood.
The company noted that the approval for the marketing of the therapy was given post the submission of successful Phase 3 results. The study comprised of patients aged between 12 years and 65 years, who were suffering from hemophilia A. The clinical trial showed that 95% of prophylaxis-treated patients reported a drop in the median overall annualised bleed rate (ABR). Also, 40% of the prophylaxis-treated patients did not report bleeds at all while not a single patient complained of inhibitors of the treatment.
Successful study results
The most common side-effects of the treatment were nausea and headache, which was found in less than one percent of patients. The approval from Japan’s Ministry now paves the way for the company to initiate its marketing efforts. In this direction, the company has already transferred the marketing authorisation to Baxalta Japan Limited from Baxter Limited.
It is to be noted that ADYNOVATE is already licensed in the U.S. for the treatment of adults aged 12 years and more. The therapy is currently under review in Europe, Canada, and Switzerland. The stock of the company surged by nearly 2% to $41.57 during the previous trading session.