Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®

Core Viewpoint - Catalyst Pharmaceuticals has received FDA approval for a supplemental New Drug Application (sNDA) to increase the maximum daily dose of FIRDAPSE® (amifampridine) for treating Lambert-Eaton myasthenic syndrome (LEMS) from 80 mg to 100 mg, enhancing treatment flexibility for patients and healthcare providers [1][2]. Group 1: Product Information - FIRDAPSE is a potassium channel blocker indicated for LEMS treatment in adults and pediatric patients aged six years and older, improving muscle function by increasing acetylcholine release at the neuromuscular junction [2]. - This approval broadens the dosing options for prescribers, as FIRDAPSE is currently the only FDA-approved treatment for LEMS [2]. Group 2: Company Commitment - The company emphasizes its dedication to meeting the evolving needs of LEMS patients and healthcare providers, believing that the increased dosing flexibility will significantly impact patient outcomes [3]. - Catalyst Pharmaceuticals is committed to developing innovative first-in-class medicines for rare and difficult-to-treat diseases, with FIRDAPSE being its flagship product [5]. Group 3: Recent Developments - In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) for treating epilepsy, and in July 2023, it obtained an exclusive license for AGAMREE® (vamorolone) for Duchenne Muscular Dystrophy, which was approved for commercialization in the U.S. on October 26, 2023 [5]. - AGAMREE became commercially available by prescription in the U.S. on March 13, 2024 [5].