Alexion Pharma: Strensiq Receives Marketing Approval In Japan - Quick Facts

(RTTNews) - Alexion Pharmaceuticals, Inc. (ALXN) announced that Japan's Ministry of Health, Labour and Welfare approved the company's New Drug Application for the use of Strensiq, or asfotase alfa, as a treatment for patients in Japan with hypophosphatasia, an ultra-rare metabolic disorder. The company noted that Strensiq is the first therapy approved in Japan for the treatment of patients with hypophosphatasia.

Alexion has submitted a Biologics License Application for Strensiq with the U.S. Food and Drug Administration, which was accepted for priority review, and received a positive CHMP opinion recommending marketing authorization for Strensiq for patients with pediatric-onset hypophosphatasia in Europe. The company said regulatory decisions in the U.S. and Europe are expected in the second half of 2015.