Investigational Drug, Firdapse, Available at No Cost to U.S. Patients with LEMS

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Investigational Drug, Firdapse, Available at No Cost to U.S. Patients with LEMS

Coral Gables drug company to make new medicine available at no cost
April 23, 2014
Evan S. Benn
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.
SCRIP
Catalyst steps up to provide LEMS patients expanded Firdapse access
April 23, 2014
Donna Young
After recognizing some patients with a rare autoimmune neuromuscular disease, known as Lambert-Eaton myasthenic syndrome (LEMS), were unable to access treatment for their disease, Florida drug maker Catalyst Pharmaceutical Partners stepped up and initiated the process to establish an expanded access program (EAP) for its experimental potassium channel inhibitor Firdapse (amifampridine phosphate).
BioPharm Insight
Catalyst to include safety data from new 3,4DAP expanded access program in LEMS as part of NDA filing executivesApril 23, 2014
Jennifer Smith-Parker
Catalyst Pharmaceutical Partners (NASDAQ:CPRX) plans to collect safety data from a new expanded access program for its Lambert-Eaton Myasthenic Syndrome (LEMS) candidate and add it to its NDA filing, said COO and CSO Steve Miller and Doug Winship, vice president of regulatory operations. The program can meet the needs of at least 500 people, said CEO and cofounder Patrick McEnany.
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