Supplementary approval for Firdapse (amifampridine) for the treatment of Lambert-Eaton myasthenic syndrome
Catalyst Pharmaceuticals, Inc. announced that the FDA has approved its supplemental New Drug Application increasing the indicated maximum daily dose of Firdapse (amifampridine) for adults and pediatric patients weighing more than 45 kg from 80 mg to 100 mg for the treatment of Lambert-Eaton myasthenic syndrome (“LEMS”)
The increased maximum daily dose offers healthcare providers and patients greater flexibility in treatment regimens for the management of LEMS. LEMS is a rare autoimmune disorder characterized by muscle weakness and fatigue. Firdapse is a potassium channel blocker indicated for the treatment of LEMS in adults and pediatric patients six years of age and older and works by increasing the release of acetylcholine, a neurotransmitter, at the neuromuscular junction, which helps improve muscle function in people with LEMS. Firdapse is currently the only U.S. approved treatment for LEMS and this approval broadens the approved dosing options for prescribers treating LEMS.
“We are pleased to receive the approval for the increased maximum daily dose of Firdapse said Richard J. Daly, President and CEO of Catalyst. “This pivotal achievement further underscores our dedication to meeting the evolving needs of LEMS patients and their healthcare providers. We believe that this milestone will have a meaningful impact on the lives of LEMS patients, offering a new level of flexibility in treatment while aligning with our overarching mission to optimize LEMS patient outcomes.”
Patients in the U.S. can access Firdapse by prescription through their healthcare providers. For those seeking more information, the Catalyst Pathways Patient Assistance Program for Firdapse offers comprehensive support, including a dedicated eam to assist families throughout the treatment journey for eligible patients. Caregivers and healthcare professionals may call 1-833-422-8259 or visit www.yourcatalystpathways.com for further details.
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