The sNDA Seeks to Increase the Indicated Maximum Daily Dose for FIRDAPSE to 100mg for the Treatment of Lambert-Eaton Myasthenic Syndrome U.S. FDA Assigned Target Action Date of June 4, 2024 CORAL GABLES, Fla., Oct. 13, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ('Catalyst' or 'Company') (Nasdaq: CPRX) today announced that the U.S.

sNDA试图将FIRDAPSE的指定最大日剂量增加至100mg，用于治疗Lambert-Eaton肌无力综合征美国FDA指定的目标行动日期为2024年6月4日CORAL GABLES，Fla。，2023年10月13日（GLOBE NEWSWIRE）-Catalyst Pharmaceuticals，Inc。（'Catalyst'或'Company'）（纳斯达克：CPRX）今天宣布，美国。

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').

美国食品和药物管理局（'FDA'或'机构'）已接受审查该公司的补充新药申请（'sNDA'），以将指定的每日最大剂量的FIRDAPSE®（阿米法普利）片剂10 mg从80mg增加至100mg用于治疗Lambert-Eaton肌无力综合征（'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.

该机构分配了2024年6月4日的处方药用户费法（'PDUFA'）行动日期。FIRDAPSE目前在美国被批准用于治疗成人和6至17岁儿童的LEMS。帕特里克·J（Patrick J.）说：“我们对该机构接受sNDA申请FIRDAPSE感到满意，这标志着我们的倡议取得了另一个里程碑，即解决LEMS患者及其希望增加每日剂量的医生的重要需求。”。

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.

催化剂主席兼首席执行官McEnany事实证明，FIRDAPSE是受LEMS影响的美国个体（包括与小细胞肺癌合并症的个体）的重要治疗选择。如果获得批准，这将为LEMS患者提供额外的指示剂量选择，这些患者可能受益于每日剂量大于80mg的FIRDAPSE，并进一步强调我们对我们服务的患者社区的坚定承诺。

We look forward to working collaboratively with the Agency during the application review process.' Lambert-Eaton myasthenic syndrome, or LEMS, is a rare autoimmune neuromuscular disorder characterized primarily by muscle weakness of the.

我们期待在申请审查过程中与该机构合作。”Lambert-Eaton肌无力综合症或LEMS是一种罕见的自身免疫性神经肌肉疾病，其主要特征是肌肉无力。