The FDA has turned down Merck’s application to expand the indication for its cholesterol-lowering drug ezetimibe (Zetia and Vytorin, Merck). This means there’s still no end in sight for this drug’s very long and very winding road. Ezetimibe is now indicated to reduce LDL cholesterol in people with hyperlipidemia. The proposed new indication was for…
FDA Panel Turns Down Expanded Indication For Ezetimibe
December 15, 2015 by Leave a Comment
An FDA advisory panel on Monday voted 10-5 against an expanded indication for Merck’s ezetimibe (Vytorin, Zetia). The current label states that the drugs have not been shown to improve cardiovascular morbidity or mortality. The proposed expanded indication was based on findings from the IMPROVE-IT trial. The panel spent most of the day trying to interpret…
Live Blog: The FDA Advisory Panel On IMPROVE-IT
December 14, 2015 by 1 Comment
Expect Intellectual Fireworks At FDA Advisory Panel On Ezetimibe
December 10, 2015 by 1 Comment
You can expect a lot of high-powered intellectual fireworks at next Monday’s FDA advisory panel considering Merck’s application to upgrade the indications for Vytorin and Zetia. Both brands contain the cholesterol-lowering drug ezetimibe, which was studied exhaustively– in many senses of the word– in the IMPROVE-IT trial. The discussion will likely focus on what to do about missing data and how to…
Newly Identified Mutations Act Like a Lifetime of Treatment with Ezetimibe
November 13, 2014 by Leave a Comment
A very large genetic study published in the New England Journal of Medicine offers compelling evidence in support of a central role for LDL cholesterol in coronary heart disease. In a series of studies analyzing blood samples from nearly 100,000 people, Sekar Kathiresan and colleagues identified 15 rare mutations that block the activity of a single gene — called Niemann-Pick…
Merck Uses Legal Threats To Stifle Negative Advice About Zetia And Vytorin In Italy
July 6, 2014 by Leave a Comment
In response to repeated legal threats, a public health doctor in Italy has withdrawn advice to curtail use of a controversial drug. The drug, ezetimibe, is a key ingredient in Zetia and Vytorin, which is manufactured by Merck. The cholesterol-lowering drug has been the subject of fierce controversy because it has never been shown to improve…
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