Catalyst Pharmaceuticals, Inc. (CPRX), a commercial-stage biopharmaceutical company, Tuesday announced that its sub-licensee, DyDo Pharma, has launched FIRDAPSE or amifampridine Tablets 10 mg in Japan for the treatment of Lambert-Eaton myasthenic syndrome or LEMS.
FIRDAPSE is the only FDA-approved therapy for LEMS, a rare autoimmune disorder characterized by muscle weakness and fatigue.
The launch expands access to this evidence-based treatment in Japan, offering a new option for patients who currently have limited choices.
DyDo Pharma, a wholly-owned subsidiary of DyDo Group Holdings, will distribute FIRDAPSE in Japan, where it was granted orphan drug designation.
This launch marks a significant milestone in Catalyst's global expansion strategy, following prior approvals of FIRDAPSE in the U.S., Europe, and Canada. Catalyst continues to focus on rare disease treatments and improving patient care.
"We are pleased that our sub-licensee, DyDo, has launched FIRDAPSE in Japan. We believe in health equity, and this launch is a testament to our ongoing efforts to increase patient access to life-changing therapies worldwide," said Richard Daly, Catalyst's President and Chief Executive Officer.
He further added that, "The launch of FIRDAPSE in Japan marks another advancement in our efforts to expand the geographic footprint of our portfolio products and paves the way for healthcare providers and patients in Japan to access this therapy."
Currently, CPRX is trading at $22.48, down by 1.32 percent on the Nasdaq.
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