FDA Advisory Committee does not recommend expanded label for Zetia (ezetimibe)- Merck
The FDA Endocrinologic and Metabolic Drugs Advisory Committee does not recommend Zetia (ezetimibe) from Merck, voting 10-5 against expanding the label. The IMPROVE-IT trial had shown that Zetia plus a statin reduced cardiovascular events by 6.4% however the Advisory Committee saw these results as 'modest' and were concerned at missing data which could have a statistical significance.
A sub-group analysis had showed that the drug had a more positive effects on diabetic patients and patients over the age of 75 but also showed little effect on non-diabetic and younger patients. A final decision will be made by the FDA.
Ezetimibe is marketed as Ezetrol in the UK, and is indicated in some cases of hypercholesterolaemia.
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