CHMP recommends expansion of Trulicity label to include results from REWIND cardiovascular and diabetes outcomes trial.- Eli Lilly

Eli Lilly and Company announced 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. Additionally, the updated label will reflect the consistent MACE risk reduction with Trulicity across major demographic and disease subgroups.

REWIND is the longest CV outcomes trial in the glucagon-like peptide-1 receptor agonist (GLP-1 RA) class (median follow-up of 5.4 years) and consisted primarily of people without established CV disease. The study had a more balanced ratio of women (46.3 percent) to men (53.7 percent) and one of the lowest median baseline A1Cs of any diabetes CV outcome trial to date (7.2 percent).