UCB drug Keppra receives further approval

A drug manufactured by UCB Pharmaceuticals has received approval for paediatric exclusivity today.

Keppra (levetiracetam) was originally secured under a patent set to expire this July but it has now been extended until January 2009.

UCB also said Keppra had been given priority review status in the US as an adjunctive treatment for the partial onset of seizures in children and infants with epilepsy.

The submission included data from a phase III randomised, double-blind, placebo-controlled trial studying the tolerability and efficacy of an oral solution of levetiracetam.

It evaluated 116 paediatric patients aged between one month and four years old suffering from refractory partial onset seizures at least twice a week yet being treated with one or two drugs.

The drug “significantly” reduced seizure frequency, according to UCB, with 43.1 per cent of patients taking levetiracetam experiencing a minimum reduction of 50 per cent during the five-day period.

This compares to 19.6 per cent of placebo-controlled subjects.

Iris Loew-Friedrich, chief medical officer of the group, said: “Acceptance and granting of priority review status reflects the need for new effective antiepileptic treatments for infants and children under four years.”

The National Society for Epilepsy states that at least 456,000 people are affected by the condition throughout the UK.