Merck & Co is pulling its cholesterol drug Tredaptive, which has been available in Europe and elsewhere (although not the USA) in response to the negative findings of a recent late-stage trial.
Less than a month ago, the company presented data from the HPS2-THRIVE study of Tredaptive (extended-release niacin/laropiprant) which enrolled 25,673 patients considered to be at high risk for cardiovascular events. Data showed that adding the pill to statin therapy did not significantly further cut the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularisations.
There was also a statistically significant increase in the incidence of some non-fatal serious side effects in the Tredaptive group, Merck said at the time. Because of the data, the company has decided not to seek approval in the USA and is now withdrawing the drug from 40 countries.
The decision to suspend the medicine came as the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee also called for Tredaptive to be withdrawn after a review of the HPS2-THRIVE data.
Tredaptive has not been a big earner for Merck, which said that it is recommending that doctors review treatment plans for patients "in a timely manner to discontinue Tredaptive and consider other changes in therapy to achieve their dyslipidaemia management goals". Patients are advised to not discontinue therapy without first speaking with their physician.