Alexion Pharmaceuticals, Inc. announced that the FDA has accepted for review the Company’s Biologics License Application (BLA) for approval of ALXN1210, the Company’s investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH). The FDA set a Prescription Drug User Fee Act (PDUFA) date of February 18, 2019, as part…
Japan Authorizes Soliris For Treatment Of Generalized Myasthenia Gravis
Soliris (eculizumab) receives marketing authorization in Japan for the treatment of patients with generalized myasthenia gravis (gMG). Japan’s Ministry of Health, Labour and Welfare has approved Alexion Pharmaceuticals, Inc.’s Soliris (eculizumab) as a treatment for patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous…