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Product update from Datamonitor

Published on 26/04/07 at 01:35pm

Schering-Plough receives Japanese approval for Zetia

Schering-Plough has received Japanese marketing approval for Zetia, a cholesterol-lowering agent that inhibits the absorption of cholesterol in the intestine.

Zetia will help Schering-Plough to access the cholesterol-management market which is one of the largest worldwide, with total global sales of $34 billion according to IMS Health.

In Japan Zetia is approved for use in patients with hypercholesterolemia, familial hypercholesterolemia or homozygous sitosterolemia. The drug will be co-marketed in Japan with Bayer Yakuhin. Schering-Plough, in collaboration with Merck, has developed and commercialized Zetia for lipid management.

Zetia, which works in the digestive tract to inhibit the absorption of cholesterol, is complementary to the class of cholesterol-lowering agents known as statins, which work in the liver to reduce the production of cholesterol. Zetia, alone or in combination with statins, has been proven to significantly improve LDL cholesterol levels. Zetia, either alone or in addition to a statin, has not been shown to prevent heart disease or heart attacks.

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UCB epilepsy drug effective for pediatric patients

Belgian firm UCB has said a phase III study has evaluated the efficacy and tolerability of its epilepsy drug Keppra as adjunctive therapy in the treatment of seizures in children.

Compared with placebo, Keppra was shown to significantly reduce the frequency of partial onset seizures in pediatric patients from one month to under four years of age, with consistent results across all stratified age groups.

"There are very few studies assessing antiepileptic drug efficacy in infants. In this well-designed randomised trial Keppra was shown to be more efficacious than placebo in controlling partial seizures in infants and young children with treatment resistant partial onset epilepsies," commented, Jesus Eric Pina-Garza, director Pediatric Epilepsy Clinical Trials, Vanderbilt University.

In this study, 43.1% of 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 said that on the basis of the positive results in younger patients with treatment resistant partial seizures, it intends to file a supplementary new drug application for Keppra.

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