Lambert-Eaton Myasthenic Syndrome (LES)

Firdapse ®  (currently approved in the EU) is the first and only approved drug for the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome in adults, a rare autoimmune disease with the primary symptoms of muscle weakness. Firdapse at a Glance Approved in the European Union Manufactured and commercialized by BioMarin in the European Union Designated as an orphan drug in the United States, the European Union and and Switzerland Regulatory Status In December 2009, Firdapse received marketing approval from the European Commission making it the first approved therapy for the symptomatic treatment of LEMS. Firdapse has been designated an orphan drug in the EU, which grants market exclusivity for ten years. Commercialization Plan Firdapse is commercialized by BioMarin in the European Union. In October 2012, BioMarin out-licensed North American rights of Firdapse to Catalyst Pharmaceutical Partners. For more information on Firdapse development plans in the U.S., please r

The Herald | HeraldOnline.com Catalyst Announces Initiation of an Expanded Access Program to Provide Firdapse at No Cost to   ... CORAL GABLES, Fla., Apr 23, 2014 (BUSINESS WIRE) -- Catalyst Pharmaceutical Partners, Inc. announced today it has begun the process required to establish an expanded access program (EAP) to make available in the United States its investigational potassium channel inhibitor, Firdapse™ (amifampridine phosphate or 3,4-DAP phosphate), to patients diagnosed with  Lambert-Eaton Myasthenic Syndrome (LEMS)  through their neuromuscular disease specialists. The product, currently in Phase 3 development, will be provided at no cost until sometime after approval. Program enrollment will begin in the next few months, pending FDA review and approvals. “As part of our ongoing commitment to the LEMS community, we are making Firdapse available to those who would like access to this investigational drug, but are unable to participate in clinical studies or tra