CHMP Issues Positive Opinion to Expand Trulicity® (dulaglutide) Label to Include Results from REWIND Cardiovascular Outcomes Trial

INDIANAPOLIS, Sept. 20, 2019 /PRNewswire/ — Eli Lilly and Company (LLY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending an update to the Trulicity® (dulaglutide) label and indication statement. The committee agreed the label should include results from the REWIND cardiovascular (CV) outcomes trial, which achieved a significant 12 percent risk reduction in major adverse cardiovascular events (MACE). The CHMP has recommended updating the Trulicity® indication to reflect both glycemic control and the impact on cardiovascular events as fundamental considerations in a treatment for people with type 2 diabetes.

source https://finance.yahoo.com/news/chmp-issues-positive-opinion-expand-104500678.html?.tsrc=rss

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