News

Catalyst Will Seek FDA Approval of Firdapse for Children

Catalyst Pharmaceuticals plans to file an application with the U.S. Food and Drug Administration (FDA) requesting that the use of Firdapse (amifampridine), an approved oral therapy for adults with Lambert-Eaton myasthenic syndrome (LEMS), be expanded to children. The announcement came after the company received a favorable decision from…

Pooled Trial Analysis Confirms Efficacy, Safety of Firdapse in Adults

Firdapse (amifampridine) improved muscle strength and response to nerve cell stimulation in adults with Lambert-Eaton myasthenic syndrome (LEMS), a pooled analysis of six clinical trials demonstrated. The findings showed that all six previous trials together “showed significant efficacy, consistent with earlier reports of beneficial efficacy” of Firdapse —…

Cholinesterase Inhibitors Alone Can Ease LEMS Symptoms, Per Report

Cholinesterase inhibitors may be useful in controlling the symptoms of Lambert-Eaton myasthenic syndrome (LEMS) in people with relatively mild disease, as highlighted in a recent case report. The findings suggest that these medications may be particularly useful for managing LEMS in countries where Firdapse (amifampridine) — the…

Jacobus Recalls 3 Lots of Ruzurgi Due to Contamination

Jacobus Pharmaceutical has issued a voluntary recall for three lots of Ruzurgi (amifampridine), a medication that is approved in the U.S. to treat people with Lambert-Eaton myasthenic syndrome (LEMS) ages 6–17. According to the company’s announcement, while doing confirmatory full testing on one of the lots, control…

Report: Use Multiple Tests to Find LEMS Antibodies

Immunofluorescence, a technique that can be used to detect antibodies associated with Lambert-Eaton myasthenic syndrome (LEMS), was negative in a 72-year-old woman, but another technique — called immunoblot — was positive for LEMS-associated antibodies. This ultimately allowed for a LEMS diagnosis and the discovery of a previously unknown tumor.

2nd Firdapse Patent Secured in US by Catalyst with 3 Still Pending

Catalyst Pharmaceuticals has secured a second U.S. patent covering Firdapse (amifampridine), an approved oral treatment for Lambert-Eaton myasthenic syndrome (LEMS). “We are pleased that this second patent for Firdapse has been issued and believe that it further enhances our intellectual property protection for Firdapse,” Patrick J. McEnany, chairman…