Eisai Inc. has submitted a supplemental application to the U.S. Food and Drug Administration (FDA) for a proposed label change for its antiepileptic drug FYCOMPA®(perampanel) CIII which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
FYCOMPA is approved as an adjunctive therapy, or an add-on treatment, in combination with another antiepileptic drug (AED), for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. Please see Important Safety Information for FYCOMPA, including Boxed WARNING for Serious Psychiatric and Behavioral Reactions, below.
Eisai submitted its application based on a new FDA communication which states that it is "acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS" as long as adequate information is provided on pharmacokinetics and possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug. Eisai has submitted such data along with the proposed new label.
"Eisai is pleased to submit this new application, which may lead to an additional treatment option for those suffering from partial onset seizures," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "As a company, we are committed to advancing treatments that will make a difference to those who are affected by epilepsy, and we're looking forward to the potential for FYCOMPA as a single agent to help more patients suffering from these types of seizures."