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Catalyst Pharmaceuticals goes to battle against FDA

A small South Florida drug maker battles the FDA to guard its turf, Catalyst is narrowly focused on treating rare neuromuscular disorders with no approved or effective treatments. It currently has one approved drug: Firdapse, the brand name for amifampridine — a compound that was developed more than 30 years ago by researchers in Paris but received its first FDA approval under Catalyst. It was the first approved drug to help people suffering from Lambert-Eaton myasthenic syndrome (LEMS), an extremely rare neuromuscular disorder that leads to debilitating muscle weakness. Approved by the FDA in November and launched in the market by Catalyst in January, Firdapse has been a huge commercial success — so successful that Catalyst’s first-quarter earnings this year were stronger than analysts expected.

This story also features expert opinions, business briefs and people in the news: Catalyst Pharmaceutical; Firdapse; Lambert-Eaton myasthenic syndrome; Ruzurgi; Jacobus Pharmaceutical

 

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