Catalyst Pharmaceuticals Inc. said the U.S. Food and Drug Administration granted priority review to its application for Firdapse as a treatment of Lambert-Eaton myasthenic syndrome, or LEMS.
LEMS is a rare autoimmune disorder characterized by muscle weakness of the limbs.
The Coral Gables, Fla.-based biotechnology company said the FDA will make a decision on the application Nov. 28.
The submission is supported by the results of two phase 3 studies.
