Firdapse amifampridine regulatory update

Catalyst announced an expanded access program in the U.S. to provide Firdapse amifampridine at no cost to treat Lambert-Eaton myasthenic syndrome (LEMS). The company expects enrollment in the program to begin "in the next few months," pending FDA approval. Last month, Catalyst completed enrollment in a Phase III trial with the potassium channel blocker to treat LEMS, a rare disorder of neuromuscular transmission caused by impaired presynaptic release of acetylcholine. The company expects to begin submission of a rolling NDA to FDA next year. ...