Firdapse oral therapy now available to LEMS patients in Japan
Medication approved last year to improve muscle strength in patients
Firdapse (amifampridine), an approved oral treatment for Lambert-Eaton myasthenic syndrome (LEMS), is now available to people in Japan with the rare autoimmune disease.
The therapy, available in the form of 10 mg tablets, was launched by Dydo Pharma. Dydo is responsible for the development and commercialization of Firdapse in Japan following a 2021 agreement established with Catalyst Pharmaceuticals, the company that holds rights to Firdapse in North America and has led the therapy’s worldwide development.
“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,” Richard J. Daly, president and CEO of Catalyst, said in a company press release.
Firdapse, used to improve muscle strength in patients, was approved in Japan late last year.
Firdapse also approved in US, Canada, EU
LEMS is an autoimmune disease in which the immune system erroneously attacks certain proteins on nerve endings. As a result, nerve cells are unable to effectively release signaling molecules that normally instruct muscles to contract. These problems in nerve-muscle communication ultimately lead to LEMS symptoms, such as muscle weakness and fatigue.
Firdapse is an oral therapy that essentially works by boosting the power of signals sent from nerve to muscle cells, thereby helping to improve muscle strength and relieve LEMS symptoms.
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.
The therapy’s approvals were supported by data from two Phase 3 clinical trials : LMS-002 (NCT01377922) and LMS-003 (NCT02970162). Together, the two studies involved more than 60 LEMS patients who were given either Firdapse or a placebo. The results demonstrated that Firdapse was better than the placebo at improving muscle strength. It also led to better scores on measures of overall health reported by clinicians or by patients themselves.
In the U.S., the therapy is approved for LEMS patients ages 6. The U.S. Food and Drug Administration last year approved an increase of the therapy’s maximum daily dose from 80 mg to 100 mg. Firdapse also is approved for adults with LEMS in Canada and the European Union.
“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,” Daly said.
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