Real-world data prove efficacy of Eisai and Bial's epilepsy treatment

Bial and Eisai have released real-world data which support the efficacy of Zebinix (eslicarbazepine acetate) in the treatment of partial-onset epilepsy in adults, as part of a post-market study of more than 2,000 patients using the drug, making it one of the largest-ever studies of its kind in the disease area.

The Euro-Esli study, which evaluated data from 14 European clinical practice studies, found that seizure freedom rates in patients taking Zebinix were 30.6% at three months, 38.3% at six months, and 41.3% at a year. Over the same periods, retention rates were 95.4%, 86.6% and 73.4%, while responder rates stood at 60.9%, 70.5% and 75.6%.

"It is most reassuring to see similar efficacy results with eslicarbazepine acetate in a routine clinical setting compared to that of clinical trials; we can be confident that this treatment is effective amongst the diversity of our ‘real’ epilepsy patients," explained Dr Vicente Villanueva, Neurologist and Epileptologist at Hospital Universitario y Politécnico La Fe in Valencia, Spain. "Real-world studies like the Euro-Esli study are important because they provide significant insight into how a drug performs in a routine medical setting, allowing us to assess the drug, to ultimately improve patient outcomes."

Zebinix received marketing authorisation in Europe for the treatment of partial-onset epilepsy in May this year. The drug’s marketing is a joint effort between Japan’s Eisai and Portugal’s Bial; the pair offer the drug under an agreement which sees Bial handle marketing across Europe and Russia alongside Eisai’s subsidiary, Eisai Europe Limited.

"These results improve our knowledge and understanding around the use of eslicarbazepine acetate in routine clinical practice and strengthen Bial’s commitment to developing and delivering beneficial treatment options for people living with epilepsy," commented Bial CEO António Portela, with Neil West, Eisai’s Vice President EMEA, Global Neurology Business Unit, adding: "These data underscore our commitment to our anti-epileptic drug product portfolio. We will continue to invest both in clinical trials and the generation of real-world evidence to improve the lives of patients living with epilepsy."