Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has approved UCB's Keppra (levetiracetam) tablets and oral solution for treating adults and children one month of age and older with epilepsy.
Subscribe to our email newsletter
Keppra was previously approved in the US as adjunctive therapy for partial onset seizures in adults and children four years of age and older with epilepsy.
The approval is backed by a Phase III, double-blind, randomized, multi-center, placebo-controlled study, that evaluated the efficacy and tolerability of Keppra oral solution in patients with refractory partial onset seizures.
In the study, Keppra-treated patients experienced at least a 50% reduction in seizure frequency during the evaluation period compared with 19.6% of placebo-treated patients.
UCB chief medical officer and executive vice president Iris Loew-Friedrich said the continuing development program with Keppra in young children demonstrates their long-term commitment to epilepsy.
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to treat severe diseases of the immune system or of the central nervous system.