Firdapse (amifampridine) for LEMS
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.
BioMarin is planning to conduct a Phase III Program and pursue FDA approval
in the U.S.
