PDUFA Date Set for November 28, 2018
CORAL GABLES, Fla., Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, announced today that its New Drug Application (NDA) for Firdapse® for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) has been accepted for a Priority Review by the U.S. Food and Drug Administration (FDA).
Priority Review is granted by the FDA to drugs with the potential to address a serious condition and, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of November 28, 2018. The submission is supported by positive results from two Phase 3 studies.
"We are delighted to have received Priority Review status for Firdapse for the treatment of LEMS and look forward to continuing to work closely with the FDA during the review process," said Patrick J. McEnany, Chairman and CEO of Catalyst. "Together with the previous grant of Breakthrough Therapy Designation, the Priority Review underscores the robust potential of Firdapse and the need for a safe and effective FDA-approved treatment for LEMS."
