CORRECTED - (OFFICIAL)-UPDATE 1-Merck unit says Tredaptive gets EU approval
(Merck corrects spelling of drug to add dropped 'e' at end of name)
CHICAGO, July 11 (Reuters) - Merck & Co (MRK.N) said on Friday its cholesterol drug that was rejected by U.S. health regulators earlier this year was approved by the European Union.
Approval for the new lipid-modifying therapy to treat LDL-cholesterol and HDL-cholesterol and triglycerides applies to 27 countries of the EU, Norway and Iceland.
The drug -- known as Tredaptive in Europe and Cordaptive in the United States -- combines nicotinic acid, or niacin, and laropiprant, a novel flushing pathway inhibitor.
In clinical studies involving more than 4,700 patients, Tredaptive reduced LDL-cholesterol, the so-called bad cholesterol, and raised HDL-cholesterol, the good cholesterol, and reduced triglycerides, a type of fat in the blood.
High LDL-cholesterol, low HDL-cholesterol and elevated triglycerides are risk factors associated with heart attacks and strokes.
Merck said Tredaptive should be used in patients in combination with statins, when the cholesterol lowering effects of statin alone is inadequate. Tredaptive also can be used alone when statins are inappropriate or not well tolerated.
The U.S. Food and Drug Administration would not approve the drug in April, saying more safety and efficacy data were required. (Reporting by Debra Sherman)
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