Title:

Levetiracetam (Keppra) Approved in European Union (EU) as Adjunctive Therapy in Children Four Years of Age and Older with Partial-Onset Seizures.

Date:

23rd September 2005

Author:

Susan Wileman Medicines Information Technician

 

Source – Druginfozone – UCB Pharma Limited has announced the levetiracetam (Keppra™) has been approved in the EU as adjunctive therapy in children four years of age and older with partial-onset seizures, with or without secondary generalisation.

Approval was based on a trial in 198 children (4-16 years old), with seizures uncontrolled by standard therapy. This showed that 45% of those on levetiracetam (60mg/kg/day for 14 weeks) has at least a 50% reduction in seizure frequency, and 7% became seizure free, compared with 19% (p=0.0002) and 1% respectively I placebo-treated patients. Somnolence was more frequently reported in the treatment group (22.8% vs 11.3%).

For more information go to: http://www.druginfozone.nhs.uk/record%20viewing/viewRecord.aspx?id=5547 63

Prepared by Susan Wileman Medicines Information Technician

Date of Preparation: 23rd September 2005