Posted by Michael Wonder on 19 Dec 2023
Catalyst Pharmaceuticals announces Firdapse new drug application submitted in Japan by partner DyDo Pharma
18 December 2023 - Catalyst Pharmaceuticals today announced that its collaboration partner, DyDo Pharma reported that it has submitted a new drug application to Japan's Pharmaceuticals and Medical Devices Agency seeking marketing approval for Firdapse (amifampridine phosphate) 10 mg tablets for the treatment of Lambert Eaton myasthenic syndrome in Japan.
The submission is based on preliminary favourable analysis results of interim data after six months into the safety phase of the registration study to evaluate the efficacy and safety of Firdapse for the treatment of LEMS.
