At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists. An FDA advisory panel last week turned out to be a much more contentious and divided than many had expected. Based on the FDA’s own analysis of last year’s Empa-Reg Outcome trial I had predicted that the…
Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists
July 5, 2016 by 1 Comment
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…
FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug
March 25, 2014 by 1 Comment
Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year. On Thursday the FDA’s Cardiovascular and Renal Drugs…
FDA Reviewers Deliver Split Opinion On The Medicines Company’s Cangrelor
February 10, 2014 by Leave a Comment
FDA reviewers presented two dramatically different views of The Medicines Company’s investigational new drug cangrelor. One reviewer says the drug should not be approved without a new trial and even states that the CHAMPION trials “were conducted unethically” and should not be approved “on that fact alone.” But two other reviewers recommend approval. … Click here to read…
FDA Panel Once Again Rejects New Indication For Rivaroxaban
January 16, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee once again turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). The nearly unanimous vote (10-0, with 1 abstention) was in line with a highly negative review from FDA staff members. … Click here to read the full post on Forbes….
FDA Advisory Panel Votes In Favor Of Approval For Merck’s Vorapaxar
January 15, 2014 by Leave a Comment
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10-1 in favor of approval for vorapaxar, Merck’s novel thrombin receptor antagonist. The “roller coaster ride” cliché might have been invented for this drug, which was the subject of tremendous early hopes followed by major disappointments and, finally, a subsequent revival. … Click here to read the entire…
Rivaroxaban Faces Uphill Battle At FDA Advisory Panel
January 14, 2014 by Leave a Comment
The third time may not be the charm. Twice before the FDA has turned down the supplemental new drug application for an acute coronary syndrome indication for Johnson & Johnson’s Xarelto (rivaroxaban). On Thursday the Cardiovascular and Renal Drugs Advisory Committee will take up the sNDA yet again, but FDA review documents posted today suggest that the company will again…
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