UPDATE: Positive CHMP opinions for Alexion's Strensiq and Kanuma

26 June 2015

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending marketing authorization of US drugmaker Alexion Pharmaceuticals’ (Nasdaq: ALXN) 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. Kanuma’s proposed indication is for long-term enzyme replacement therapy in patients of all ages with lysosomal acid lipase deficiency (LAL-d).

Final decision expected 3rd-qtr 2015

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