EU Panel Votes to Expand Dulaglutide Indication Based on REWIND

Megan Brooks


September 20, 2019

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended updating the indication (and label) for dulaglutide (Trulicity, Lilly) to include results of the REWIND cardiovascular outcomes trial, which showed a 12% reduction in risk for major adverse cardiovascular events (MACE).

The CHMP has recommended updating the dulaglutide 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," Lilly said in a news release.

Dulaglutide is a once-weekly injectable glucagon-like peptide–1 (GLP-1) receptor agonist for the treatment of type 2 diabetes. With median follow-up of 5.4 years, REWIND is the longest cardiovascular outcomes trial in the GLP-1 class. The trial included primarily people without established cardiovascular disease.

The REWIND study results were reported in June at the 2019 American Diabetes Association Scientific Sessions, as reported by Medscape Medical News.

In presenting the results, study chair Hertzel Gerstein, MD, professor of medicine at McMaster University and Hamilton Health Sciences, Ontario, Canada, said, "The REWIND trial was an ambitious study that conclusively assessed the effects of dulaglutide on people with type 2 diabetes both with and without prior cardiovascular disease (CVD). The reduction in CV events observed in a wide range of people with diabetes regardless of sex, baseline CVD, age, or HbA1c level is compelling."

CHMP Backs Qtrilmet

The CHMP also decided at its September meeting to recommend approval of the fixed-dose three-drug combination of metformin hydrochloride/saxagliptin/dapagliflozin (Qtrilmet, AstraZeneca) for treatment of type 2 diabetes.

It will be available as modified-release tablets containing 850 mg of metformin hydrochloride, 2.5 mg of saxagliptin, and 5 mg of dapagliflozin; or 1000 mg of metformin hydrochloride, 2.5 mg of saxagliptin, and 5 mg of dapagliflozin.

Qtrilmet is indicated in adults aged 18 years or older who have type 2 diabetes mellitus to improve glycemic control when metformin with or without sulphonylurea and either saxagliptin or dapagliflozin does not provide adequate glycemic control and when already being treated with metformin and saxagliptin and dapagliflozin.

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