European committee recommends dulaglutide label update to reflect REWIND findings
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended a label update for the GLP-1 receptor agonist dulaglutide to reflect positive findings from the REWIND cardiovascular outcomes trial and to include the medication’s CV benefits in the indication for use, according to a press release from Eli Lilly.
The committee agreed the label should include results from REWIND, which demonstrated dulaglutide (Trulicity) reduced the risk for nonfatal myocardial infarction, nonfatal stroke and CV death by 12% compared with placebo among a large cohort of adults with type 2 diabetes with and without established CVD. The study was the first major CV outcomes trial for a diabetes therapy to include a large primary prevention population.
The Committee for Medicinal Products for Human Use (CHMP) recommended updating the dulaglutide indication to reflect both glycemic response and the impact on CV events as “fundamental considerations” in a treatment for people with type 2 diabetes, according to Lilly. Additionally, the updated label will reflect the consistent CV risk reduction with dulaglutide observed across major demographic and disease subgroups.
“The REWIND trial found that Trulicity significantly reduced major cardiovascular events and had a consistent effect in people with and without established cardiovascular disease,” Dawn Brooks, PhD, global development leader for Trulicity at Lilly, said in the release. “We are pleased with this opinion recognizing the importance of these data, which demonstrate the benefits of Trulicity in a broad range of people with type 2 diabetes.”
The REWIND data follow other positive CV findings for the GLP-1 receptor agonist class. In 2017, the FDA approved an expanded indication for the GLP-1 receptor agonist liraglutide (Victoza, Novo Nordisk) to include language in the prescribing information that the drug can reduce risks for major adverse CV events, MI, stroke and CVD among adults with type 2 diabetes and established CVD, based on findings from the LEADER trial.
In a meta-analysis of seven large CV outcomes trial published in The Lancet Diabetes & Endocrinology in August and reported by Endocrine Today, researchers found that treatment with GLP-1 receptor agonists reduces major adverse CV events by 12%, all-cause mortality by 12% and hospitalization for heart failure by 9% among adults with type 2 diabetes when compared with placebo.
REWIND, presented at the American Diabetes Association Scientific Sessions in June, was the longest CV outcomes trial in the GLP-1 receptor agonist class (median follow-up time, 5.4 years) and had one of the lowest median baseline HbA1c levels of any diabetes CV outcome trial, according to Lilly.
This decision is now referred for final action to the European Commission, which grants approval in the European Union. The FDA is also reviewing the REWIND data, according to Lilly. – by Regina Schaffer
Disclosure: Brooks is global development leader for Trulicity at Lilly.