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Catalyst Pharmaceuticals announces plans to resubmit new drug application for Firdapse

Coral Gables, Florida
Wednesday, February 14, 2018, 18:00 Hrs  [IST]

Catalyst Pharmaceuticals, a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, announced the results of its recent Type C meeting with the US Food and Drug Administration (FDA). Prior to the meeting, Catalyst had provided the FDA with its preliminary data package for the proposed NDA resubmission, including clinical, non-clinical, regulatory and abuse liability elements. The preliminary data package included the recently reported positive top-line results from a required second, confirmatory phase 3 clinical trial (LMS-003) of Firdapse for the symptomatic treatment of LEMS, as well as the recently completed FDA-required abuse liability studies demonstrating that Firdapse does not have abuse potential. The minutes of the meeting received from the FDA reflect the FDA's advice to Catalyst that its proposed filing package will be sufficient for resubmission of an NDA for Firdapse, and Catalyst currently anticipates resubmitting its NDA for Firdapse for LEMS to the FDA by the end of the first quarter of 2018.

As previously reported, Catalyst is presently conducting a phase 3 double-blind placebo-controlled clinical trial evaluating Firdapse for the treatment of congenital myasthenic syndromes (CMS), and Catalyst expects to report top line results from the trial in the second half of this year. Catalyst is currently evaluating its options for the most appropriate and efficient path forward to hopefully include CMS in any approved labeling for Firdapse.

"We remain on track to resubmit our NDA for Firdapse in the first quarter of this year," stated Patrick J. McEnany, president and chief executive officer, of Catalyst Pharmaceuticals. "Based on our discussions with the FDA, we believe that we have a clear regulatory pathway forward, and we will continue to work collaboratively with the FDA as we seek to bring FDA approved therapies forward for the treatment of LEMS and CMS."

 

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