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EMA Starts Review of Tredaptive, Pelzont, Trevaclyn Medicines

12/21/2012 | 05:46am US/Eastern

LONDON--The European Medicines Agency, or EMA, Friday said it has started a review of the safety and efficacy of Tredaptive, Pelzont and Trevaclyn, identical medicines that are used to treat adults with dyslipidaemia, particularly combined mixed dyslipidaemia and primary hypercholesterolaemia.

MAIN FACTS:

-Review was triggered because the Agency was informed by the pharmaceutical company Merck, Sharp & Dohme of the preliminary results of a large, long-term study comparing the clinical effects of adding these medicines to statins (standard medicines used to reduce cholesterol) with statin treatment alone.

-Study raises questions about the efficacy of the medicine when added to statins, as this did not reduce the risk of major vascular events compared with statin therapy alone.

-Preliminary results saw a higher frequency of non-fatal but serious side effects in patients taking the medicines than in patients only taking statins.

-Pharmacovigilance Risk Assessment Committee (>> PRODUCTIVITY TECHS CORP) will assess the data and make a recommendation to the Committee on Medicinal Products for Human Use (>> Champion Industries, Inc.), which will issue an opinion on the regulatory action required.

-Opinion is expected in January 2013.

-Write to Tapan Panchal at tapan.panchal@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

Stocks mentioned in the article : PRODUCTIVITY TECHS CORP, Champion Industries, Inc.
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