- Firdapse (amifampridine) is the first and only available drug for the treatment of the rare autoimmune disease Lambert-Eaton myasthenic syndrome (LEMS). It is approved in the EU, but not the U.S.
- Firdapse has performed well in phase III trials, demonstrating benefit in patients with LEMS, a disease that greatly weakens afflicted patients' muscles.
- Catalyst is hiring 25 new employees to focus on Firdapse, with the understanding that a U.S. approval, and subsequent launch, is likely.
Catalyst has committed to hiring 25—and possibly 35—new employees on the strength of the Firdapse data. In the clinical trial, a randomized, double-blind study in which patients were treated for 91 days, LEMS patients showed marked improvement in their quantitative myasthenia gravis scores, the primary endpoint of the trial.
Catalyst is prepping for Firdapse's launch and initiating an expanded access program for LEMS patients.