FDA approves Alexion's Soliris for myasthenia gravis

FDA approved an sBLA for Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) to treat refractory generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AChR) antibody-positive.

The company said about 5-10% of myasthenia gravis patients are anti-AchR antibody-positive and continue to have severe symptoms and complications despite current therapies. In August, Alexion spokesperson Arne Naeveke told BioCentury he estimates there are about 60,000-80,000 total myasthenia gravis patients in the U.S. Soliris has Orphan Drug status in the U.S. for the indication...