FDA Accepts Alexion Pharmaceuticals’s SOLIRIS® (Eculizumab) Supplemental Biologics License Application for Refractory Generalized Myasthenia Gravis

U.S. FDA News

Connecticut-based Alexion Pharmaceuticals, Inc. announced today that the FDA has accepted its supplemental Biologics License Application (sBLA) for SOLIRIS® (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.  According to Alexion, the submission is supported by phase III data from the REGAIN study.

Eculizumab is a humanized monoclonal antibody currently used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

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