The marketing-authorization holder of mentioned drugs Merck Sharp & Dohme Ltd, has already begun informing regulatory agencies about suspending availability of these medicines across the EU. As a result, doctors should no longer prescribe these medicines and seek for alternatives in patients’ treatments as they will no longer be available on market starting from 21 January 2013.
According to the statement from Merc’s official web page:
“Patients currently taking TREDAPTIVE are our priority, and we are committed to continue to work with regulatory agencies around the world to ensure that physicians have appropriate information as we take steps to suspend the availability of TREDAPTIVE”
The decision was based on the data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study, from which the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) concluded that “the benefits of Tredaptive, Pelzont and Trevaclyn no longer outweigh the risks of side effects”.
In the study HPS2-THRIVE, the combination of nicotin acid and laropiprant therapy was found not to reduce the risk of major vascular events such as heart attack and stroke significantly when compared to statin therapy alone. There was, however, noticed the increase in the number of side effects like bleeding, myopathy, infections and new-onset diabetes in the group of nicotin acid/laropiprant treatment.
Tredaptive was sold in approximately 40 countries with the sales through the first three quarters of 2012 of approximately $13 million.
By Jacek Plewka
CEbiotech.com Editorial Team
2018-02-24 19:42:10 +0100
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