Merck's big PhIII failure on cholesterol drug spurs an EMA review
Just hours after Merck ($MRK) spelled out that its one-time blockbuster hopeful Tredaptive had failed a huge late-stage study with more than 25,000 patients--proving both ineffective at reducing the risk of major coronary events while raising an unspecified danger from serious adverse events--the EMA stepped in to call for a quick review of a cholesterol drug that is currently being sold in several countries on the continent.
The EMA had approved Tredaptive despite the FDA's rejection back in 2008, accepting Merck's case when the FDA demanded a big, long trial to satisfy its questions about the safety and efficacy of the treatment, which is designed to raise levels of HDL using a combination of laropiprant and nicotinic acid.
"The study raises questions about the efficacy of the medicine when added to statins, as this did not reduce the risk of major vascular events (serious problems with the heart and blood vessels, including heart attack and stroke) compared with statin therapy alone," the EMA added in a statement. "In addition, in the preliminary results a higher frequency of non-fatal but serious side effects was seen in patients taking the medicines than in patients only taking statins."
Like Merck, the EMA recommended that doctors stop prescribing Tredaptive--also sold as Pelzont and Trevaclyn--to new patients but shouldn't stop providing the drug to patients already taking it. And the EMA isn't planning to take very long to complete the review. Regulators say they'll have a decision on the future of Tredaptive--which only garnered about $13 million in sales--in January.
- here's the press release