Monotherapy approved to treat epilepsy in Europe

23 May 2017

Portugal's largest drugmaker Bial and Japanese pharma major Eisai (TYO: 4523) have announced approval from the European Medicines Agency to market Zebinix (eslicarbazepine acetate) as a monotherapy to treat epilepsy.

The drug, which is already indicated in Europe as an adjunctive therapy, was approved on the basis of results from a Phase III study, published a year ago, comparing the treatment with twice-daily carbamazepine.

While the trial showed slightly lower levels of efficacy, tolerability was marginally improved on the current standard of care.

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