September 30, 2022
Catalyst Pharmaceuticals CPRX announced that the FDA approved its supplemental new drug application (sNDA) for Firdapse (amifampridine) tablets in 10 mg dosage to include pediatric patients (six years and older) for treating Lambert-Eaton myasthenic syndrome (“LEMS”).
The company submitted an sNDA to the FDA for the use of Firdapse in treating pediatric LEMS patients in the first quarter of 2022. LEMS is an ultra-rare disease autoimmune disorder characterized by muscle weakness of the limbs. Post the sNDA approval by the FDA, Firdapse is now a treatment option in the United States for all LEMS patients beyond six years of age.
Firdapse (amifampridine phosphate) is a nonspecific, voltage-dependent, potassium (K+) channel blocker for the treatment of Lambert Eaton myasthenic syndrome (LEMS) in adults and pediatric patients six years of age and older.