Phase 3 Trial Starts in Japan to Aid Firdapse’s Potential Approval

Phase 3 Trial Starts in Japan to Aid Firdapse’s Potential Approval

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Phase 3 Trial Starts in Japan to Aid Firdapse’s Potential Approval

Catalyst Pharmaceuticals has announced its partner DyDo Pharma has launched a Phase 3 registrational trial in Japan to evaluate the safety and effectiveness of Firdapse (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS). A registrational trial is designed to obtain sufficient clinical data to support the filing of an application for a therapy’s regulatory approval. Currently, Firdapse is not yet available to LEMS patients in Japan. “We are pleased with the important progress being made by…

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