Firdapse approved to treat LEMS patients in Japan

Firdapse (amifampridine) has been approved in Japan to treat people with Lambert-Eaton myasthenic syndrome (LEMS). The therapy will be supplied in the form of oral tablets containing 10 mg of amifampridine, according to Catalyst Pharmaceuticals, the company that holds Firdapse’s licensing rights in North America. In collaboration with…

DyDo seeks approval of Firdapse for LEMS in Japan

DyDo Pharma is seeking approval of Firdapse (amifampridine) to treat Lambert-Eaton myasthenic syndrome (LEMS) in Japan. A decision from Japan’s Pharmaceuticals and Medical Devices Agency is expected in September. DyDo’s application was submitted in collaboration with Catalyst Pharmaceuticals, which developed Firdapse. DyDo is leading the development…

2 more US patents expected for Catalyst’s Firdapse in next 2 months

The U.S. Patent and Trademark Office has sent a notice of allowance for two additional patents for Firdapse (amifampridine), Catalyst Pharmaceuticals’ approved therapy for Lambert-Eaton myasthenic syndrome (LEMS), for claims related to its bioavailability under fasting and fed dosing conditions. Catalyst, which has licensing rights in North…

Ruzurgi for Children and Adults With LEMS Returning to Canada

A decision by the Federal Court of Appeal of Canada is restoring the availability of Ruzurgi (amifampridine) to treat children and adults with Lambert-Eaton Myasthenic Syndrome (LEMS) in that country, Medunik Canada announced. Specifically, the court returned for a second time the notice of compliance, or approval, …

Teva Seeking FDA OK to Make Generic Version of Firdapse for LEMS

Teva Pharmaceuticals is seeking authorization from federal regulators in the U.S. to produce and sell a generic version of Firdapse (amifampridine), an approved treatment for Lambert-Eaton myasthenic syndrome (LEMS). Firdapse, marketed by Catalyst Pharmaceuticals, was approved by the U.S. Food and Drug Administration in 2018 as the…