Alexion Pharma: CHMP Issues Positive Opinion For Soliris - Quick Facts

(RTTNews) - Alexion Pharmaceuticals Inc. (ALXN) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion to extend the current therapeutic indication for Soliris (eculizumab) to include the treatment of refractory generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody-positive. The final decision from the European Commission is anticipated in the third quarter of 2017.

The CHMP based its opinion on clinical data from the Phase 3 REGAIN study and its long-term extension study.