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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.

The FDA requested the second pivotal trial as well as abuse liability studies when the agency issued a refuse to file letter in response to the company's initial NDA filing in 2016 – all of which has been completed, the company said on Nov. 27. (Also see "Catalyst Collapses On FDA Firdapse Refusal " - Scrip, 18 February, 2016.) Catalyst officials said during a same-day call with analysts and investors that the Coral Gables, Fla

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