European Medicines Agency (EMA) accepts Bial’s submission for once-daily epilepsy treatment (eslicarbazepine acetate) as monotherapy for partial-onset seizures
Porto, Portugal | Hatfield, UK | 17 May 2016 – BIAL announces today that the European Medicines Agency (EMA) has accepted Bial’s application to review recent clinical trial data for 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. Eslicarbazepine Acetate is currently indicated in Europe as an adjunctive therapy in adults with partial-onset seizures, with or without secondary generalisation. In the US, eslicarbazepine acetate 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, explains, “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”.