CHMP Issues Positive Opinion To Expand Jardiance®, Synjardy® And Glyxambi® Labels To Include Positive Effects On Cardiovascular And Renal Outcomes

Kurt HarringtonIndustry News, RegulatoryLeave a Comment

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INGELHEIM, Germany & INDIANAPOLIS–(BUSINESS WIRE)–Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion to update the labels of Jardiance® (empagliflozin), Synjardy® (empagliflozin and metformin) and Glyxambi®(empagliflozin and linagliptin) to include additional important data from the landmark EMPA-REG OUTCOME® trial on heart failure and kidney endpoints.

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