UCB Reports Positive Opinion from EMEA for Paediatric Indication for Keppra®


Brussels (Belgium) August 1st, 2005: UCB today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion, recommending approval of Keppra® as adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalisation, in children four years of age and older with epilepsy. "The CHMP positive recommendation is an important milestone towards making Keppra® available to European children with epilepsy", commented Peter Verdru MD, Vice President Clinical Research, UCB. The CHMP's opinion is now forwarded to the European Commission for review and final decision, which is expected within 90 days. In June 2005, the US Food and Drug Administration (FDA) approved the pediatric indication for Keppra® under priority review.
 

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