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…
IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics
August 31, 2015 by 1 Comment
The beneficial effects of ezetimibe are found almost exclusively in patients with diabetes, according to an update of the influential IMPROVE-IT trial presented on Sunday at the European Society of Cardiology meeting in London. The new finding may lead to questions about the widely accepted interpretation of the main finding of the trial, which is that it provided strong support for…
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…
What You Need To Know About IMPROVE-IT
November 7, 2014 by Leave a Comment
The IMPROVE-IT trial will be big news when its results are finally presented on November 17 during the annual meeting of the American Heart Association. The results of the trial–underway for nearly a decade– have been long and eagerly awaited by everyone interested in cardiovascular medicine. The trial could impact the future sales of a key Merck drug, ezetimibe, though because it is nearing…
IMPROVE-IT Trial Scheduled For Presentation In November
August 12, 2014 by Leave a Comment
Results of the eagerly-awaited and highly controversial IMPROVE-IT trial are finally going to be revealed. The American Heart Association has announced that the trial will be presented by Chris Cannon on November 17 at 11:51 AM (central time) in Chicago at the group’s annual scientific sessions . IMPROVE-IT compared the effect on cardiovascular outcomes of the statin simvastatin with Vytorin (the combination of…
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…
FDA Approves Combination Of Ezetimibe And Atorvastatin
May 3, 2013 by Leave a Comment
The FDA has approved a new combination drug from Merck for lowering cholesterol. The drug, which will carry the brand name of Liptruzet, is a combination of two previously approved cholesterol-lowering drugs, ezetimibe and atorvastatin. Merck said the new drug (pronounced “LIP-true-zett”) would be commercially available starting next week. Liptruzet will be available as a…
Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path
January 3, 2013 by 1 Comment
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed…
After a year-long review FDA finds nothing new about vytorin
January 8, 2009 by Leave a Comment
The FDA has finally completed its review of ENHANCE that it started in January 2008. It’s finding: there was no difference in clinical outcome between the vytorin-treated and the simvastatin-treated patients in clinical outcomes, though vytorin, as expected, had greater efficacy in lowering cholesterol. The FDA advises patients that, pending the results of IMPROVE-IT, “patients…
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