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news.Eisai's UK subsidiary Eisai Europe has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa (perampanel) for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures.
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Fycompa is indicated to treat PGTC seizures in adult and adolescent patients from 12 years of age with idiopathic generalized epilepsy.
Discovered and developed by Eisai, Fycompa is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.
PGTC seizures accounts for about 60% of generalized epilepsy and approximately 20% of all epilepsy cases.
The positive opinion is based on data from a multicenter, double-blind, randomized, placebo-controlled, parallel-group study (Study 332) to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients with PGTC seizures receiving one to a maximum of three anti-epileptic drugs.
The company said that as one of the primary endpoints of the trial, the responder rate for Fycompa was 64.2%, which was a statistically significant improvement over the responder rate for placebo of 39.5%.
In September 2012, Fycompa was launched in Europe as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older.
Fycompa is currently approved for this indication in more than 45 countries and has been launched in over 25 countries.