BIAL has announced that the European Medicines Agency (EMA) has accepted Bial’s application to review recent clinical trial data for Zebinix(R) (eslicarbazepine acetate) for its use as a once-daily monotherapy in the treatment of adult patients with newly-diagnosed partial-onset (focal) epilepsy.
Partial-onset seizures, also known as focal, are the most common type and are therefore an important first target for treatment. Zebinix(R), (eslicarbazepine acetate), is currently indicated in Europe as an adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation.
In America, eslicarbazepine acetate(Aptiom(R)) is indicated for the treatment of partial-onset seizures as monotherapy or as an adjunctive therapy.
Commenting on the submission, António Portela, CEO of Bial, explained, ‘It is a significant milestone in Bial’s commitment to help people who live with epilepsy. We have been developing eslicarbazepine acetate for many years and it’s very encouraging to have the monotherapy submission acceptance. We hope it will become available for those living with epilepsy and for those who manage the condition.’
The submission was based on the results from a Bial sponsored Phase III study in adult patients with newly diagnosed partial-onset seizures which demonstrates that treatment with monotherapy is as effective as controlled-release carbamazepine, a standard of care, and is well-tolerated.
