To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: European Union Approves Anti-Epileptic Keppra (Levetiracetam) URL: http://www.pslgroup.com/dg/1E2BFA.htm Doctor's Guide October 2, 2000
BRUSSELS, BELGIUM -- October 2, 2000 -- UCB S.A. announced that its anti-epileptic agent Keppra™ (levetiracetam) has received marketing authorization from the European Commission as adjunctive therapy in the treatment of partial onset seizures, with or without secondary generalization, in adults with epilepsy. Keppra is a highly effective anti-epileptic agent with a wide margin of safety and straightforward pharmacokinetics that distinguish it from other currently available antiepileptic drugs. This profile may facilitate the clinical management of patients with epilepsy by providing an effective drug with a safer and less-complicated therapeutic strategy.1 The UK, Germany and Scandinavia are anticipated to be the first EU markets likely to launch the treatment, following on from the US and Swiss launches earlier this year. Gerd Johnscher, Medical and Regulatory Affairs Director at UCB Pharma, commented, "The marketing authorization from the European Commission of Keppra will be welcomed by everyone across Europe involved in the management of epilepsy. Given that the patients involved in the trials all had refractory disease (i.e. they had previously been unresponsive to treatment), the combination of high response and seizure freedom rates seen together with minimal side-effects experienced confirm that Keppra represents a significant advance in the treatment of epilepsy." The effectiveness of Keppra as adjunctive therapy in the treatment of partial seizures in adults was demonstrated in three multi-centre, randomized, double-blind, placebo-controlled clinical studies. 904 patients from Europe and the USA, who had experienced refractory partial seizures with or without secondary generalization for at least one to two years and had taken one or two standard anti-epileptic agents, participated in the studies. Pooled results from these trials showed that 28 percent (at a dose of 1000mg/day) to 41 percent (at a dose of 3000mg/day) of patients responded to Keppra (where response is defined as a 50 percent reduction in rate of seizures). At a dose of 3000mg/day, 8 percent of patients became entirely seizure free.2,4 Professor Heinz Gregor Wieser, of the University Hospital in Zurich, Switzerland, added, "There has been an extremely positive response to Keppra in Switzerland following its launch earlier in the year, and it will be interesting to follow Keppra's impact across the various European markets. Keppra represents another step forward in the search for the ideal anti-epileptic agent." He concluded, "Based on preliminary open label data and its pre-clinical profile, Keppra has the potential to become a broad spectrum treatment for epilepsy and the results of these studies are awaited with interest by the prescribing community." UCB plans to study the possible applications of Keppra through further clinical studies in other seizure types and patient groups. Clinical studies have shown that Keppra is generally well tolerated. The most frequently reported undesirable effects in clinical studies involving Keppra in combination with other antiepileptic agents were somnolence, asthenia (lack or loss of strength) and dizziness. They were usually mild to moderate in intensity, appeared to occur predominantly during the first four weeks of treatment and decreased over time. 15 percent of patients receiving Keppra, compared to 11.6 percent of patients receiving placebo (NS), discontinued therapy or had a dose reduction as a result of an adverse event.3 In the two clinical studies evaluating 3000 mg/day, 8 percent of patients became entirely seizure free for the complete evaluation period, at a dose of 3000 mg/day, compared to 0 percent and 1 percent of the placebo group.2,4 In April 2000 the USA became the first country to launch Keppra, closely followed by Switzerland in May 2000. Switzerland, as a non-EU member, has its own medicinal products review committee. As a result, the approval and launch of Keppra in Switzerland was able to precede that of the rest of Europe. 50 million people worldwide have epilepsy. 5 References: 1 Patsalos PN. Pharmacokinetic profile of levetiracetam: toward ideal characterisitics. Pharmacology & Therapeutics 85 (2000) 77-45. 2 Ben-Menachem E. and Falter U., Epilepsia, in press. 3 UCB SA Data on file. 4 Cereghino J.J. et al, Levetiracetam for partial seizures - Results of a double-blind, randomized clinical trial. Neurology Vol.55 N°2 July 2000 236 - 242 5 Brodie MJ, Dichter MA. Anti-epileptic Drugs. NEJM 1996;334:168-175. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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