Firdapse amifampridine regulatory update

Catalyst said FDA granted Orphan Drug designation to Firdapse amifampridine to treat congenital myasthenic syndromes. The company plans to submit an NDA to FDA for Firdapse to treat Lambert-Eaton myasthenic syndrome (LEMS) in 3Q15. Firdapse has breakthrough therapy designation in the U.S. and Orphan Drug designation in the U.S. and Switzerland for LEMS, a rare disorder of neuromuscular transmission caused by impaired presynaptic release of acetylcholine. The potassium channel blocker is approved for the indication in the EU, where it has Orphan Drug status. ...