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Phase III Data Support Catalyst's NDA Resubmission For Firdapse

 
• By Mandy Jackson

Catalyst executives note that the company has completed everything the FDA requested to support resubmission of Firdapse for its first two rare disease indications – a second Phase III study in LEMS and abuse liability studies.

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Catalyst Pharmaceuticals Inc. plans to resubmit a new drug application (NDA) to the US FDA in the first quarter of 2018 for Firdapse (amifampridine) in the treatment of Lambert-Eaton myasthenic syndrome (LEMS) now that it has positive top-line results from a second Phase III clinical trial.

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