European regulators have ruled Merck & Co’s cholesterol medication Tredaptive should no longer be available in the region as its benefits do not outweigh its risks.
The European Medicines Agency (EMA) announced its decision after completing a review of trial data that suggested the drug, when used in addition to a statin, was no better than taking the statin on its own, yet carried an increased risk of non-fatal but serious side effects, including blood and lymphatic disorders, gastrointestinal problems and infections.
It follows Merck’s own decision when the trial results were released to suspend sales of Tredaptive (extended-release niacin/laropiprant) worldwide, where it had been available in 70 countries and sold under the brand names Pelzont, Trevaclyn and Cordaptive.
The EMA’s confirmation now seals Tredaptive’s fate, and the regulator recommended patients taking the medicine should make a non-urgent appointment with their doctor to discuss treatment options.
Doctors were also told they should no longer prescribe the drug under any of its names.
The recommendation will now be sent the the European Commission to become law.
Tredaptive was initially approved in 2008 as a new way to prevent problems associated with cardiovascular disease, such as heart and stroke, by increasing levels of high-density lipoprotein (HDL) cholesterol.
This type of cholesterol is thought to offer protection against such events, compared to the harmful low-density lipoprotein (LDL), which is targeted by standard treatments, such as statins.
It’s been a problematic form of therpay, however, and other HDL-raising drugs, including Roche’s dalcetrapib and Pfizer’s torcetrapib, have faced late-stage development issues.
Outside Europe, Merck has already said it does not intend to file for Tredaptive’s approval in the US based on the trial results.