225  0 Kommentare Catalyst Pharmaceuticals Announces FDA Acceptance of the Supplemental New Drug Application for FIRDAPSE

CORAL GABLES, Fla., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX) today announced that the U.S. Food and Drug Administration ("FDA" or "Agency") has accepted for review the Company's supplemental New Drug Application ("sNDA") to increase the indicated maximum daily dosage of FIRDAPSE (amifampridine) Tablets 10 mg from 80mg to 100mg for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS"). The Agency assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 4, 2024. FIRDAPSE is currently approved in the U.S. for the treatment of LEMS for adults and for children ages six to seventeen.  

"We are pleased by the Agency's acceptance of the sNDA filing for FIRDAPSE, marking yet another milestone in the advancement of our initiative to address an important need of LEMS patients and their physicians who desire an increased daily dosage," stated Patrick J. McEnany, Chairman and CEO of Catalyst. "FIRDAPSE has proven to be an important therapeutic option for individuals in the U.S. affected by LEMS, including those comorbid with small-cell lung cancer. If approved, this will offer additional indicated dosage options for LEMS patients who may benefit from a FIRDAPSE daily dosage greater than 80mg and further underscores our unwavering commitment to the patient communities we serve. We look forward to working collaboratively with the Agency during the application review process."

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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 enough of this neurotransmitter results in muscle weakness in LEMS patients.