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Pharmaceuticals / Submissions and Approvals

FDA Approves Firdapse for Treatment of LEMS

Dec. 11, 2018

The FDA gave the go-ahead for Catalyst Pharmaceuticals’ Firdapse (amifampridine) for the treatment of adults with Lambert-Eaton Myasthenic Syndrome (LEMS).

LEMS is a rare autoimmune disease that causes proximal muscle weakness and fatigue in patients, with life-threatening symptoms possible when a patient’s respiratory muscles are weakened. It is estimated to affect 1 in 100,000 individuals in the U.S.

The FDA’s approval was based on positive results for two Phase 3 studies in which patients treated with the drug saw rapid, steady and significant improvements in muscle function, as well as a reduction in fatigue and weakness.

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