Merck withdraws Tredaptive
pharmafile | January 14, 2013 | News story | Sales and Marketing | EMA, Merck, tredaptive
Merck is mounting a global operation to withdraw its cholesterol-lowering drug Tredaptive from the market following safety concerns.
The company says it is “taking steps to suspend the availability” of Tredaptive (extended-release niacin/laropiprant) tablets worldwide.
The European Medicine Agency’s Pharmacovigilance Risk Assessment Committee recommended the move following the drug’s disappointing performance last year in the HPS2-THRIVE trial.
It failed to reach its primary endpoint – reducing major vascular events – and researchers also found a statistically significant increase in some non-fatal serious adverse events in patients in the Tredaptive arm compared to those receiving statin therapy.
“Patients currently taking Tredaptive are our priority,” insisted Merck’s chief medical officer Michael Rosenblatt.
“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,” he added.
Doctors should stop prescribing the drug, Merck says, and review treatment plans for those patients who are already taking it – although the company insists people should not simply stop treatment without consultation.
Tredaptive has been approved in 70 countries, including in Europe – although not the US – and had sales of $13 million in the first three quarters of 2012.
Merck says it has begun informing regulators in countries where the medicine is currently available, with the timing of Tredaptive’s suspension “to be based on individual country regulations and processes”.
Tredaptive did not significantly reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularisations compared to statin therapy.
The adverse events seen with the drug fell into the following categories: blood and lymphatic, gastrointestinal, infections, metabolism, musculoskeletal, respiratory and skin.
Detailed study results from HPS2-THRIVE should be available before April this year.
Adam Hill
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