Merck & Co., Inc.'s Tredaptive is Under Review by European Medicines Agency After Failed Trial
Published: Dec 26, 2012
The European Medicines Agency said it has launched a review of Merck & Co Inc's cholesterol drug Tredaptive after the medicine failed a U.S. trial assessing its effectiveness and safety. Although the commercial fallout from any decision to pull the drug from the market in Europe would be limited, it would be a blow to Merck's reputation. Bernstein analyst Tim Anderson estimates that Tredaptive sales in Europe and other non-U.S. markets are running at only around $50 million a year, compared to Merck's overall revenue of $47 billion. The drug is designed to raise "good" HDL cholesterol but the 25,000 patient study found it didn't do better at preventing heart attacks, deaths or strokes than traditional statin drugs that lower "bad" LDL cholesterol. The large-scale trial also found that patients taking the drug suffered more non-fatal but serious side effects than those only taking statins.