Jardiance's Cardiovascular Benefit Claim Bodes Well For Other Products Too
US labeling for Boehringer/Lilly's SGLT-2 inhibitor empagliflozin includes results from MACE primary endpoint and its individual components in the EMPA-REG trial, but indication statement is limited to CV risk reduction benefit.
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Lack of significant reduction on cardiovascular deaths or a composite of major events may have been due to enrollment of a healthier population relative to other studies, said investigators from the DECLARE-TIMI 58 outcomes study, which was reported at the AHA meeting.
The latest drug development news and highlights from our FDA Performance Tracker.
Cardiovascular and non-CV safety findings from completed outcomes trials to date for eight drugs, as well as the relative paucity of preapproval CV data available for anti-diabetic agents prior to a December 2008 guidance that mandated dedicated risk assessments, may inform advisory committee's view on continuing need for large safety trials.