EU CHMP recommend change to authorisation for Zebinix (eslicarbazepine) in epilepsy- Bial-Portela

The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending changes to the terms of the marketing authorisation for the medicinal product Zebinix (eslicarbazepine), from Bial-Portela. The CHMP adopted an extension to the existing indication as follows: Zebinix is indicated as adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation. In addition, Zebinix will be available as an oral suspension (50 mg/ml).

Comment: With more convenient dosing and a purported improved safety profile over Trileptal and Tegretol, Zebinix /Aption (eslicarbazepine acetate) is forecast to become the best-selling pipeline antiepileptic drug. Factoring monotherapy approval and first-line use, epilepsy-specific sales are forecast to top $400 million across the seven major markets by 2019.