Empagliflozin May Be Poised To Gain CV Indication

–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…

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First Outcomes Trial Results For PCSK9 Drugs Will Come In 2016

In less than a year we may know a whole lot more about the PCSK9 inhibitors than we do now. Since the approval earlier this year of Repatha (evolocumab, Amgen) and Praluent (alirocumab, Regeneron and Sanofi) critics and benefit managers have recommended strict limitations on use of the drugs because of the absence of evidence showing clinical benefit….

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