Alexion's gMG drug gains Japanese approval

Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved 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 immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).

Soliris, from the USA’s Alexion Pharmaceuticals (Nasdaq: ALXN), is the first and only complement inhibitor approved in Japan as a treatment for these patients. In the Phase III REGAIN study and its ongoing open-label extension study, Soliris demonstrated treatment benefits for patients with anti-AChR antibody-positive gMG who had previously failed immunosuppressive treatment and continued to suffer from significant unresolved disease symptoms, which can include difficulties seeing, walking, talking, swallowing and breathing.

“Soliris represents an important treatment advance for patients in Japan with anti-AChR antibody-positive gMG who continue to suffer from significant unresolved disease symptoms despite existing treatment options,” said John Orloff, executive vice president and head of R&D at Alexion.