Catalyst’s Partner DyDo Pharma Approved to Launch FIRDAPSE® for LEMS Treatment in Japan

Catalyst Pharmaceuticals announced that DyDo Pharma, its sub-licensee in Japan, received approval from the Ministry of Health, Labor and Welfare of Japan to commercialize FIRDAPSE® (amifampridine) Tablets 10 mg for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). This milestone opens a new chapter for patients in Japan affected by this rare autoimmune disorder, which leads to muscle weakness and fatigue.

Richard J. Daly, CEO of Catalyst, expressed his enthusiasm for the approval, recognizing it as a significant step in expanding the reach of FIRDAPSE beyond the U.S. and affirming its therapeutic impact. In the U.S., FIRDAPSE is the only FDA-approved treatment for LEMS in both adults and children aged six and above. Its effectiveness stems from its ability to enhance neuromuscular transmission, improving muscle function.

Catalyst’s ongoing global expansion strategy is underscored by its focus on in-licensing and developing therapies for rare diseases. DyDo Pharma, a subsidiary of DyDo Group Holdings, will lead FIRDAPSE’s commercialization in Japan. This approval is particularly meaningful given the lack of treatment options for LEMS patients, which affects around 3% of those with small-cell lung cancer.

The approval marks an important breakthrough for Japanese patients with LEMS, who now have access to an effective and accessible treatment option, offering them new hope for a better quality of life.