Regulatory Agencies Review New Treatment for Generalized Myasthenia Gravis

Regeneron Pharmaceuticals announced that both the U.S. FDA and European Medicines Agency have accepted regulatory applications for cemdisiran. This potential treatment is for adult patients with anti-acetylcholine receptor antibody-positive generalized myasthenia gravis. If approved, cemdisiran could become the first siRNA therapy for gMG, potentially offering a subcutaneous quarterly dosing option.