Firdapse

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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 refer to the Catalyst website.

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