Catalyst's Firdapse becomes first FDA-approved drug for rare autoimmune disease

FDA approved a resubmitted NDA for Firdapse amifampridine phosphate from Catalyst Pharmaceuticals Inc. (NASDAQ:CPRX). The agency said Firdapse is the first drug approved to treat Lambert-Eaton myasthenic syndrome (LEMS).

In 2016, FDA issued a refusal-to-file letter for Firdapse to treat LEMS and congenital myasthenic syndromes, requiring a second trial in patients with LEMS and several abuse liability studies...