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.
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.