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The FDA expanded indications for the diabetes drug dulaglutide (Trulicity) to include major adverse cardiovascular event (MACE) risk reduction in adults with type 2 diabetes, drugmaker -- and not just for patients with established cardiovascular disease.

Lilly may now market dulaglutide for primary and secondary MACE prevention for adults with established cardiovascular disease but also for those without it but who possess multiple risk factors.

First approved in 2014, the once-weekly injectable is available for adults with type 2 diabetes, and not recommended for children or those with type 1 diabetes.

Other members of the glucagon-like peptide 1 receptor agonist (GLP-1 RA) class also carry an indication for MACE risk reduction -- including liraglutide (Victoza) and semaglutide (Ozempic) -- as do several of the so-called SGLT-2 inhibitors. For all these drugs, however, the indication is restricted to patients with established cardiovascular disease.

Dulaglutide is the only anti-diabetic agent indicated for primary prevention of cardiovascular events in patients who only have two or more risk factors for cardiovascular disease, such as tobacco use, hypertension, dyslipidemia, or abdominal obesity (BMI at least 32).

Approval relied heavily on results from the phase III REWIND trial, presented at the 2019 meeting of the American Diabetes Association, which found a 12% risk reduction for a composite of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes. In this broad population of adults with diabetes and varying degrees of cardiovascular risk, dulaglutide's benefit was mainly driven by a drop in nonfatal stroke risk.

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