Recommendations for two Eisai epilepsy drugs
pharmafile | May 28, 2012 | News story | Sales and Marketing | CHMP, Eisai, Zonegra, epilepsy
European regulators are likely to approve two of Eisai’s epilepsy drugs after advisers recommended both of them.
First-in-class Fycompa (perampanel) has got a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in the most common type of epilepsy, called partial onset.
And existing brand Zonegran gets its nod as monotherapy for the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy.
It has already been approved in Europe for seven years as adjunctive therapy.
After the thumbs-up from the CHMP, both products could receive European Union marketing approval in as little as three months.
Improving seizure control remains one of the most pressing unmet needs in epilepsy, with up to 40% of patients becoming refractory to treatment.
Seizures can vary from brief lapses of attention to severe and prolonged convulsions and may happen less than once a year or several times per day.
The CHMP opinion on Fycompa is cheering news for Eisai: the US Food and Drug Administration last year refused to file it, saying more information on the once-daily pill was needed.
If approved in Europe it would be used as an adjunctive treatment of partial-onset seizures, with or without secondarily generalised seizures, in patients aged 12 years and older.
The drug, an AMPA receptor antagonist, has a different mechanism to current antiepileptic drugs and blocks postsynaptic glutamate AMPA receptors.
These are present in almost all excitatory neurons, transmit signals stimulated by glutamate within the brain, and are believed to play a role in several central nervous system disorders, including epilepsy.
The CHMP based its decision on phase III studies, taking in 1,480 epilepsy sufferers, which showed consistent efficacy and tolerability.
Primary and secondary endpoints were percentage change in seizure frequency, 50% responder rate, percentage reduction of complex partial plus secondarily generalized seizures, and evaluation for dose response.
As well as Zonegran, Eisai currently markets Zebinix (eslicarbazepine acetate) as adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation, and Inovelon (rufinamide) for the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in patients over four years old
Last year GlaxoSmithKline and Valeant’s Potiga (ezogabine) was approved by the FDA – but some big drugs in this therapy area, including GSK’s blockbuster Lamictal and Johnson & Johnson’s Topomax, are due to go off patent.
Adam Hill
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