MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis
The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. This milestone makes Soliris the first and only treatment available for pediatric gMG patients, addressing a significant unmet need in this population. The decision builds on clinical trial data from adult gMG patients, along with pharmacokinetic and safety data from pediatric ...