Alexion's Strensiq approved in Japan for ultra-rare metabolic disease

Japan’s Ministry of Health, Labor and Welfare has approved the New Drug Application from US pharma company Alexion Pharmaceuticals (Nasdaq: ALXN) for Strensiq (asfotase alfa) as a treatment for hypophosphatasia (HPP).

HPP is an ultra-rare deadly metabolic disorder, for which Strensiq is the first therapy approved in Japan. Alexion expects initial patients with HPP will start commercial treatment with Strensiq by late third-quarter 2015.

David Hallal, chief executive of Alexion, said: “The rapid approval of the Strensiq NDA in Japan underscores the devastating nature of HPP and the life-transforming impact that Strensiq can provide to Japanese patients living with HPP. We are delighted that this regulatory approval in Japan marks the first treatment option for patients with HPP, and we look forward to urgently working with the healthcare authorities to make Strensiq available to Japanese patients who can benefit from this therapy. I would also like to thank the investigators, patients, and their families in Japan who participated in the clinical trial that led to this approval.”