Please login to the form below

Not currently logged in

EMA recommends suspension of Merck's Tredaptive

Pharma company had already anticipated decision by withdrawing product worldwide

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.

21st January 2013

From: Sales, Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company
Cello Health Insight

Cello Health Insight is the global market research arm of Cello Health. With 35 years’ sector experience, we specialise in...

Latest intelligence

Products come and go, but a pharma company’s most valuable, durable asset is its reputation, writes Duncan Mackenzie-Reid and Simon Grist
A quest for innovative solutions
UCB looks to the future through a PRISM...
Big data, privacy and the rise of genomic testing
Blue Latitude Health speaks to Johan Christiaanse, Marketing Director at BGI, to find out how the medical profession can overcome one of the major barriers to precision medicine – big...