Coral Gables-based Catalyst Pharmaceutical Partners soon will make its investigational drug Firdapse available at no cost to patients with a certain autoimmune disorder.
The drug, which is supposed to relieve muscle weakness in people with Lambert-Eaton Myasthenic Syndrome, is entering the final phase of its clinical trials. Catalyst said it expects to submit an application for Firdapse’s approval with the U.S. Food and Drug Administration next year.
Catalyst has been leading the development of Firdapse in the United States since 2012; the drug already is government-approved and commercially available in Europe.
During the U.S. approval process, Catalyst said it will establish an expanded-access program to make Firdapse available for free to patients with LEMS.
“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 travel to sites where it is available,” Catalyst CEO Patrick J. McEnany said in a statement.