Clinical Development Programs and Beyond
Since Catalyst announced its strategic collaboration with BioMarin Pharmaceuticals and obtained the North American rights to amifampridine in 2012, we have made great strides in making our corporate mission a reality. Our clinical studies involving the efficacy and safety of amifampridine for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) have produced positive, statistically significant results. To date, amifampridine is the only evidence-based, FDA-approved treatment for adult patients with Lambert-Eaton Myasthenic Syndrome (LEMS). We are currently preparing a submission seeking to expand the indication the US to include some pediatric LEMS patients.
The US FDA approved Firdapse® (amifampridine) tablets for use in adults with Lambert-Eaton myasthenic syndrome ( LEMS) on November 28, 2018, and Catalyst began its commercial launch in early 2019.
