Catalyst Pharmaceuticals (CPRX) announced that its Japanese sub-licensee, DyDo Pharma, has received approval from the Ministry of Health, Labor and Welfare of Japan for the commercialization of FIRDAPSE (amifampridine) 10 mg tablets. This medication is intended for patients with Lambert-Eaton Myasthenic Syndrome (LEMS) in Japan.
FIRDAPSE, or amifampridine, is already approved in the United States for treating LEMS in both adults and pediatric patients aged six years and older. DyDo Pharma operates as the rare disease pharmaceutical subsidiary wholly owned by DyDo Group Holdings.
