Swiss regulators have given the green light to a new monotherapy indication for Eisai’s epilepsy treatment Zonegran (zonisamide).
Swissmedic approved the drug for use on its own to treat partial seizures (with or without secondary generalisation) in adults with newly diagnosed epilepsy.
The licence makes Zonegran the sixth anti-epileptic to be approved as a monotherapy in Switzerland, joining the likes of Novartis’ Tegretol (carbamazepine).
Dr Christiane Kordeuter, medical director for Eisai Switzerland, said: “The approval of zonisamide monotherapy in Switzerland is a very welcome advance for both doctors and patients. The new extended monotherapy indication for Zonegran will provide patients with an alternative option to help improve their seizure control.
“The monotherapy indication will become an increasingly important option in the early treatment of partial epilepsy,” she added.
The Swissmedic approval follows last year’s monotherapy licence for Zonegran from the EMA.
Swiss approval was based on a double-blind, randomised, multicentre study of 583 newly-diagnosed adult partial epilepsy patients, which compared the efficacy and safety of once-daily zonisamide with twice-daily controlled release carbamazepine as monotherapy.
The study’s primary endpoint was the proportion of seizure-free patients at six months and Eisai said Zonegran demonstrated “high response rates for achieving seizure freedom” that were “similar to controlled release carbamazepine”.
The company said most Zonegran patients were free from seizures at the target dose of 300mg and that its drug was considered non-inferior to Novartis’ Tegretol.
Eisai, whose other epilepsy drugs include Fycompa, Zebinix and Inovelon, has ambitions to become a top-three player in the therapy area, but it has faced market access struggles with Fycompa in Germany, where regulators have so far refused to recommend it.