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Catalyst Pharmaceuticals Advances sNDA Submission Plans To Increase Indicated Maximum Dose For FIRDAPSE® From 80 mg Per Day To 100 mg Per Day
Concluded Positive FDA Type-C Meeting in Early May 2023 Company On Track to Submit an sNDA Early in the Third Quarter of 2023 CORAL GABLES, Fla., May 09, 2023
About this update from Catalyst Pharmaceuticals, Inc.
[{"type":"text","content":"Concluded Positive FDA Type-C Meeting in Early May 2023 Company On Track to Submit an sNDA Early in the Third Quarter of 2023 CORAL GABLES, Fla., May 09, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (\"Catalyst\") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare diseases, today reported that it recently concluded a Type C meeting with the U.S. Food and Drug Administration (\"FDA\" or \"Agency\") regarding its plans to file a supplemental New Drug Application (\"sNDA\") to increase the maximum daily dosage of FIRDAPSE® (amifampridine) from 80mg to 100mg for the treatment of Lambert Eaton myasthenic syndrome (\"LEMS\"). Based on the feedback received from the meeting, Catalyst believes it now has the information necessary to complete the submission of its sNDA for marketing approval in the U.S. early in the third quarter of 2023. \"The meeting was held for alignment of our strategy to support a proposed maximum 100-milligram daily dose indication of FIRDAPSE,\" said Patrick J. McEnany, Chairman and Chief Executive Officer of Catalyst. \"We thank the Agency for their collaboration in reviewing our submitted materials and providing their feedback. Based on the positive outcome of the meeting, we remain on track to file an sNDA submission early in the third quarter of 2023. If approved, we believe this change will address an important need for LEMS patients, caregivers, and physicians who may benefit from an optimized therapy.\" FIRDAPSE® (amifampridine) Tablets 10mg is currently approved in the U.S. for the treatment of LEMS in adults and for children ages six to seventeen with an indicated maximum daily dose of 80 milligrams. Lambert-Eaton myasthenic syndrome, or LEMS, is a rare autoimmune neuromuscular disorder characterized primarily by muscle weakness of the limbs. The disease is caused by an autoimmune reaction where antibodies are formed against voltage-gated calcium channels on nerve endings, which damages the channels. These calcium channels are responsible for the transport of charged calcium atoms that activate the biochemical machinery responsible for releasing acetylcholine. Acetylcholine is the neurotransmitter responsible for causing muscles to contract, and the failure to release e...