News

FDA Accepts Catalyst’s NDA for Firdapse with Priority Review Status for LEMS

The U.S. Food and Drug Administration has accepted Catalyst Pharmaceuticals’ new drug application (NDA) for Firdapse (amifampridine phosphate) for Lambert-Eaton myasthenic syndrome (LEMS), with priority review status. Firdapse is a formulation of amifampridine phosphate in development for the treatment of LEMS as well as other conditions. Several clinical studies have…

LEMS May Coexist with Other Autoimmune Disorders in Cancer Patients, Case Study Finds

Lambert-Eaton myasthenic syndrome (LEMS) can occur along with other autoimmune diseases affecting the nervous system, namely limbic encephalitis, in patients with lung cancer, a case study found. The study, “Coexistence of Lambert–Eaton myasthenic syndrome and autoimmune encephalitis with anti-CRMP5/CV2 and anti-GABAB receptor antibodies in small cell lung cancer: A case…

Researchers Report Rare Case of LEMS with Mostly Eye Symptoms

University of Missouri researchers presented a rare case of Lambert–Eaton myasthenic syndrome (LEMS) that initially showed eye muscle weakness as a primary symptom in a 59-year-old woman, according to a report in the journal Cureus. Myasthenia gravis and LEMS are two autoimmune disorders that share a…

Catalyst Seeks FDA Approval of Firdapse for Treatment of LEMS

Catalyst Pharmaceuticals filed a New Drug Application (NDA) with the U.S. Food and Drug Administration for Firdapse (amifampridine) as a treatment for Lambert-Eaton myasthenic syndrome (LEMS). “We are pleased to reach this regulatory milestone and believe that our NDA submission contains all of the necessary information…