FDA approves Firdapse for the treatment of adults with Lambert-Eaton Myasthenic syndrome (LEMS).- Catalyst Pharma + Biomarin

Catalyst Pharmaceuticals, Inc. announced that the FDA has approved Firdapse (amifampridine) 10 mg tablets for the treatment of adults with Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse is expected to be commercially available early in the first quarter of 2019.

LEMS is a rare autoimmune disease that affects approximately 1 in 100,000 people in the United States. The most common symptoms of LEMS are proximal muscle weakness and fatigue. Symptoms can be life threatening when the weakness involves respiratory muscles. Approximately 50% of LEMS patients have an underlying malignancy, typically small cell lung cancer. Firdapse becomes the first FDA approved treatment for LEMS.