Posted by Michael Wonder on 07 Aug 2020
Catalyst Pharmaceuticals’ Firdapse (amifampridine phosphate) receives marketing approval in Canada for patients with LEMS
6 August 2020 - Catalyst Pharmaceuticals today announced that Canada’s national health care regulatory agency, Health Canada, has approved the use of Firdapse (amifampridine) for the treatment of patients in Canada with Lambert-Eaton myasthenic syndrome, an ultra-rare, debilitating and potentially life-threatening neurodegenerative condition.
Firdapse was approved under priority review by Health Canada.
The marketing application submitted to Health Canada included safety and efficacy data from Catalyst’s two previously reported multi-national clinical trials evaluating Firdapse for the treatment of patients with LEMS, and the data from these trials was used to support the new drug submission to Health Canada.
