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Alexion : FDA Oks Soliris To Treat Patients With Generalized Myasthenia Gravis

Alexion Pharmaceuticals Inc. (ALXN) said that the U.S. Food and Drug Administration has approved Soliris or eculizumab as a treatment for adult patients with generalized myasthenia gravis or gMG who are anti-acetylcholine receptor or AchR antibody-positive.

In the Phase 3 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. These patients are at an increased risk of disease exacerbations and crises that may require hospitalization and intensive care and may be life-threatening. These patients represent approximately 5-10% of all patients with MG.

The FDA based its approval of the extended indication for Soliris on comprehensive clinical data from the Phase 3, randomized, double-blind, placebo-controlled, multicenter REGAIN study (ECU-MG-301).

Soliris is approved in the European Union for the treatment of refractory gMG in adults who are anti-AchR antibody-positive. Alexion's new drug application in Japan for Soliris as a treatment for patients with anti-AchR antibody-positive refractory gMG has been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW). Soliris has received Orphan Drug Designation (ODD) for the treatment of patients with MG in the U.S. and EU, and for the treatment of patients with refractory gMG in Japan.

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