$ALXN Analyst Blog

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Alexion Hypophosphatasia Drug Strensiq Approved in Japan – Analyst Blog

Alexion Pharmaceuticals, Inc. ALXN announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Strensiq for patients suffering from hypophosphatasia. The company expects initial patients with HPP in Japan to start commercial treatment with Strensiq toward the end of the third quarter of 2015.

We note that Alexion has submitted a biologics license application for Strensiq to the FDA and has been granted priority status for the same. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has rendered positive recommendations relating to the marketing authorization of Strensiq. The final decision on Strensiq in both the U.S. and Europe are expected in the second half of 2015.

Strensiq enjoys orphan drug designation by the FDA, EMA and the MHLW.

Our Take

We are pleased with the pipeline progress at Alexion. Strensiq will provide a treatment option to patients suffering from hypophosphatasia considering that it is the first approved treatment for the disease in Japan.

Approval of the candidate would reduce the company’s dependence on Soliris, currently its sole marketed product. The product is approved in the U.S., EU, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Alexion is also developing Soliris for other indications.

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