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Lilly : CHMP Issues Positive Opinion To Expand Trulicity Label

Eli Lilly and Co. (LLY) said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP issued a positive opinion recommending an update to the Trulicity or dulaglutide label and indication statement.

The committee agreed the label should include results from the REWIND cardiovascular outcomes trial, which achieved a significant 12 percent risk reduction in major adverse cardiovascular events or 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.

In addition, the updated label will reflect the consistent MACE risk reduction with Trulicity across major demographic and disease subgroups.

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