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Catalyst Pharmaceuticals Receives U.S. FDA Approval For Increased Maximum Daily Dose For FIRDAPSE®
Catalyst PharmaceuticalsCatalyst Pharmaceuticals(US:CPRX) Newsfilter·2024-05-30 17:41

Core Insights - The FDA has approved Catalyst Pharmaceuticals' 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 for patients over 45 kg [1][2][3] - This approval enhances treatment flexibility for healthcare providers and patients managing LEMS, a rare autoimmune disorder characterized by muscle weakness and fatigue [2][3] Company Overview - Catalyst Pharmaceuticals is a commercial-stage biopharmaceutical company focused on developing and commercializing novel medicines for rare and difficult-to-treat diseases [1][5] - FIRDAPSE is currently the only FDA-approved treatment for LEMS, and the recent approval broadens the dosing options available to prescribers [2][5] - The company has also acquired U.S. commercial rights to FYCOMPA® and AGAMREE®, expanding its product portfolio in the neurology and rare disease sectors [5] Patient Support Initiatives - Catalyst offers the Catalyst Pathways® Patient Assistance Program for FIRDAPSE®, providing comprehensive support to eligible patients and their families throughout the treatment journey [3]