The US Food and Drug Administration (US FDA) has accepted for review the Eisai’s supplemental New Drug Application (sNDA)for its in-house developed antiepileptic drug Fycompa (perampanel)for the treatment of primary generalised tonic-clonic seizures (PGTC), a severeform of seizures, in patients 12years or older.
Acceptance of the application indicates that the FDA has found the company's submission to be sufficiently complete to review. This sNDA was submitted to the FDA by Eisai’s US subsidiary Eisai Inc.on August 19, 2014.
Furthermore, an application seeking approval of this additional indication for the EU was also submitted on the same day to the regulatory authority in Europe. Fycompa is a first-in-class antiepileptic drug discovered and developed by Eisai. With epileptic seizures being primarily mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity a t postsynaptic AMPA receptors. Fycompa is approved in more than 40 countries primarily in Europe and North America as an adjunctive treatment for partial-onset seizures (with or without secondary generalised seizures) in patients with epilepsy aged 12 years and older, and was launched in the United States in January 2014.
Eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to Fycompa as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.