UCB's adjunctive epilepsy treatment approved in EU

Belgian biopharmaceutical company, UCB, has received approval from the European Commission (EC) for Keppra (levetiracetam), an adjunctive therapy for the treatment of primary generalised tonic-clonic (PGTC) seizures in adults and adolescents with Idiopathic Generalised Epilepsy (IGE).

The new indication represents the fifth EU approval for Keppra in epilepsy and the second EU approval for the drug in a generalised seizure type. Keppra is also approved in tablet and oral solution forms in the US.

Keppra is already indicated in the EU for the following:

* Monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy

* Adjunctive therapy for partial onset seizures with or without secondary generalisation in adults and children from four years of age with epilepsy

* Adjunctive therapy for myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME)

The efficacy and tolerability of Keppra with IGE experiencing PGTC seizures has been demonstrated in a clinical trial presented at the 60th Annual Meeting of the American Epilepsy Society in San Diego in December 2006.

The 24-week, double-blind, placebo-controlled study of adjunctive Keppra included 164 patients aged between four to 65 years (adults, adolescents and a limited number of children) experiencing refractory idiopathic generalised epilepsy with three or more PGTC seizures over an eight-week baseline. Subjects received dose escalation over four weeks to a target dose of 3,000 mg/ day (60 mg/kg/day for paediatric patients), and the target dose was evaluated over 20 weeks.

Patients receiving Keppra in this study experienced at least a 50 per cent reduction in PGTC seizure frequency a week, compared with placebo. Keppra was well tolerated and fatigue was the adverse effect most commonly reported. With continued long-term treatment, 47.4 per cent and 31.5 per cent of patients taking Keppra were free of tonic-clonic seizures for at least six months and one year, respectively.

Professor Perucca of the University of Pavia, Italy, said: "PTGC seizures are the most serious seizure type within the generalised epilepsies. In the trial supporting this application, relatively high PGTC seizure freedom rates were observed with Keppra in previously drug refractory patients. This new approval supports a broad spectrum of efficacy and adds to the growing data and patient experience with Keppra as adjunctive therapy across partial and generalised seizure types."

Troy Cox, president CNS operations at UCB, added: "Since Keppra was launched in 2000 as adjunctive therapy for partial onset seizures, the clinical development programme has focused on an ever-widening range of seizure types. This latest approval is a further step toward our goal of seizure freedom, with minimal side-effects, for as many people with epilepsy as possible."