Alexion's Soliris granted new indication in EU

The European Commission approved an expanded label for Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to include treatment of refractory generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody positive.

Alexion will initially launch Soliris in Germany for the indication and is “evaluating launches” in other EU countries. An sBLA for Soliris to treat the ultra-rare subset of myasthenia gravis is under FDA review with an Oct. 23 PDUFA date. It is also under review in Japan for the indication...