Novo Nordisk's Gabitril: Thinking Beyond Partial Seizure Control

A new antiepileptic drug, Novo Nordisk's Gabitril (tiagabine), may prove effective as monotherapy in children, the elderly and in treating other seizure types, according to clinical trial data presented at a Novo Nordisk-sponsored satellite symposium at the European Congress of Epileptology held in the Hague, the Netherlands, this month.

Gabitril, with a unique mode of action licensed as add-on therapy for partial seizures (with or without secondary generalization) is effective and well-tolerated, data from 3,200 patient years of exposure conclude. This is the first GABA uptake inhibitor to receive marketing approval; medical approval was granted in France in June (Marketletter June 24); pricing approval has not yet been given by the French authorities. Gabitril's European Union approval is being processed through the European Medicines Evaluation Agency system, and further EU approvals are expected within the next year, a company spokesman told the marketletter. The product was discovered by Novo Nordisk and is licensed to Abbott Laboratories for marketing in the USA, Canada and Mexico.