Eisai epilepsy drug sees EMA nod
pharmafile | May 27, 2015 | News story | Research and Development, Sales and Marketing | Eisai, Fycompa, ema. epilepsy
Eisai’s UK subsidiary has received a positive opinion from the European Medicines Agency for using Fycompa for the adjunctive treatment of seizures in patients with idiopathic generalised epilepsy.
The green light for Eisai Europe comes via the EMA’s Committee for Medicinal Products for Human Use (CHMP), and means Fycompa (perampanel) could be used to treat primary generalised tonic-clonic (PGTC) seizures in adult and adolescent patients from 12 years of age.
The Tokyo-headquartered firm says in a statement: “Fycompa is a first-in-class anti-epileptic drug. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.”
The company will be pleased with some good news for Fycompa, as recently it lashed out at a major German health assessment body – calling its stance on its drug ‘deeply regrettable’.
The Japanese firm was objecting to the Federal Joint Committee (G-BA)’s assessment on insurance reimbursement that Fycompa has ‘no additional benefit’ compared to conventional anti-epilepsy drugs.
But in this latest news the CHMP based its opinion on a randomised, placebo-controlled, parallel-group study (Study 332) to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients with PGTC seizures – receiving between one and three anti-epileptic drugs.
As one of the primary endpoints of the study, the responder rate for Fycompa was 64.2%, which was a statistically significant improvement over the responder rate for placebo at 39.5 per cent.
In addition a reduction in PGTC seizure frequency was noted in the Fycompa group, which was also statistically significant when compared to the placebo group in the trial.
PGTC seizures are one of the most common and severe forms of generalised seizures, accounting for around 60% of generalised epilepsy and around 20% of all epilepsy cases.
Brett Wells
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