EC approvals include Alexion's Kanuma, Strensiq

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said the European Commission approved MAAs for Kanuma sebelipase alfa to treat lysosomal acid lipase deficiency (LAL-D) and Strensiq asfotase alfa to treat bone manifestations of pediatric-onset hypophosphatasia (HPP). The company plans to launch both products in October, initially only in Germany.

Kanuma is under FDA review with a Sept. 8 PDUFA date. Alexion gained the recombinant human lysosomal acid lipase (LAL) enzyme replacement therapy through its acquisition of Synageva BioPharma Corp. in June. ...