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news.The US Food and Drug Administration (FDA) has accepted for review Eisai's supplemental new drug application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel to treat primary generalized tonic-clonic (PGTC) seizures.
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Fycompa is an oral medication and is the first FDA-approved non-competitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid) glutamate receptor antagonist.
Perampanel CIII was approved by the FDA in October 2012 and it was made available in January 2014.
Currently, Fycompa is indicated as an adjunctive treatment for partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy age 12 years and older.
Eisai chief clinical officer and president of Neuroscience & General Medicine PCU Eisai Product Creation Systems Lynn Kramer said: "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."
Epilepsy is a disease of the brain characterized by unprovoked seizures that can affect a variety of mental and physical functions and it is one of the most common neurological diseases, affecting 2.2 million people in the US, according to the Institute of Medicine.