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Merck suspends Tredaptive worldwide

Trial demonstrates increased risk of serious adverse events

Merck & Co has suspended the sale of cholesterol drug Tredaptive after a study demonstrated the drug was no better than currently available statins, yet increased the risk of serious adverse events.

The decision is in line with an ongoing probe by the European Medicines Agency (EMA) into the drug, which was approved in Europe in 2008 but has since shown it may be not be as effective as once thought.

Specifically, the HPS2-THRIVE study found that when Tredaptive ((extended-release niacin/laropiprant) was added to regular statin therapy, it did not further reduce the risk of the combination of coronary deaths, nonfatal heart attacks, strokes or revascularisations.

On top of this, patients were more likely to suffer from non-fatal side effects, such as blood and lymphatic disorders, gastrointestinal problems and infections.

In order to implement the suspension, Merck said it is working with regulatory agencies in each of the 70 countries where it is available to inform healthcare professionals of the decision.

Physicians are recommended to stop prescribing Tredaptive, which is also sold under the brand names Pelzont, Trevaclyn and Cordaptive, while all patients taking the drug should undergo a review of their treatment plan.

Tredaptive is designed to work by increasing the level of high-density lipoprotein (HDL) cholesterol, which is thought to protect against cardiovascular disease, thereby supporting the use of statins, which work by reducing levels of the harmful low-density lipoprotein (LDL) cholesterol.

Drugs that work in similar ways have also faced problems during development, including Roche's dalcetrapib and Pfizer's torcetrapib, neither of which made it past phase III.

Tredaptive's future now looks bleak as a treatment in dyslipidaemia and hypercholesterolaemia, although considering it made just $13m during the first three quarters of 2012, Merck's annual revenues won't be affected too greatly.

The company had already decided not to file for approval in the US based on the negative trial results and had also previously said it should not be prescribed to any new patients.

14th January 2013

From: Sales, Regulatory



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