Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's Supplemental New Drug Application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel for the treatment of primary generalized tonic-clonic (PGTC) seizures, a severe form of seizures, in patients 12 years and older. FYCOMPA™ (perampanel) CIII, which was approved by the FDA in October 2012 and became available in January 2014, is currently indicated as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 years and older.
The sNDA was submitted to the FDA on August 19, 2014. Acceptance of the sNDA indicates that the FDA has found the company's submission to be sufficiently complete to review. "Eisai remains dedicated to advancing epilepsy care for patients, and the acceptance of this sNDA represents an important step toward expanding treatment options for patients whose PGTC seizures are not controlled by their current medication," said Lynn Kramer, Chief Clinical Officer, President, Neuroscience & General Medicine PCU Eisai Product Creation Systems, Eisai, Inc.