Alexion Pharmaceuticals, Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions recommending marketing authorization of Strensiq (asfotase alfa) and Kanuma (sebelipase alfa). The proposed indication for Strensiq is for long-term enzyme replacement therapy in patients with pediatric-onset hypophosphatasia (HPP) to treat the bone manifestations of the disease. The proposed indication for Kanuma is for long-term enzyme replacement therapy in patients of all ages with lysosomal acid lipase deficiency (LAL-d). Based on the CHMP’s positive recommendations, final decisions from the European Commission are expected in the third quarter of 2015, after which the Company will begin the country-by-country reimbursement processes. Currently, there are no therapies approved for the treatment of HPP or LAL-d.

“The CHMP positive opinions for Strensiq and Kanuma are significant milestones in bringing these therapies to infants, children, and adults suffering from HPP and LAL-d in Europe,” said David Hallal, Chief Executive Officer of Alexion. “Both Strensiq and Kanuma are highly innovative enzyme replacement therapies that, if approved, will be the first treatments available for patients with HPP and LAL-d, two life-threatening and ultra-rare metabolic disorders.”

For more details, go to: http://news.alexionpharma.com/press-release/company-news/alexion-receives-chmp-positive-opinions-strensiq-asfotase-alfa-and-kanuma