Baxalta :ADYNOVATE Approved To Treat 12 Years & Older With Hemophilia A In Japan

(RTTNews) - Baxalta Inc. (BXLT) said that the Ministry of Health, Labour and Welfare in Japan approved ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment, for patients 12 years and older with hemophilia A.

ADYNOVATE is built on ADVATE [Antihemophilic Factor (Recombinant)], the world's most widely used FVIII treatment for hemophilia A with more than 12 years of patient experience.

The approval was based on positive results of a Phase 3, prospective, global, multi-center, open label, non-randomized study in patients 12 to 65 years of age with hemophilia A. The study found that previously-treated patients in a twice-weekly prophylaxis arm had a 95 percent reduction in the median overall annualized bleed rate (ABR) compared to those treated on-demand [1.9 vs. 41.5, respectively].

During the study, nearly 40 percent (n=120) of prophylaxis-treated patients experienced zero bleeds.No patients developed inhibitors to the treatment; the most common adverse reactions (=1 percent of subjects) were headache and nausea.

Following approval from the Ministry of Health, Labour and Welfare on March 28, the marketing authorization was transferred from Baxter Limited to Baxalta Japan Limited. In the United States, ADYNOVATE is currently licensed for use in adult and adolescent patients (12 years and older) and is under regulatory review for use in pediatric and surgical settings. ADYNOVATE is also under regulatory review in Canada, Switzerland and Europe.

ADYNOVATE is not indicated for the treatment of von Willebrand disease.