The US Food and Drug Administration (FDA) has approved the sodium-glucose cotransporter type 2 (SGLT2) inhibitor canagliflozin (Invokana, Janssen) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes who have established cardiovascular disease (CVD).
With FDA approval of the supplemental new drug application, canagliflozin becomes the first oral diabetes drug indicated to reduce the risk of myocardial infarction (MI), stroke, or death due to a cardiovascular cause, the company said in a news release.
Empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), another SGLT2 inhibitor, is allowed by the FDA to claim reduced cardiovascular mortality on its labeling.
Another type 2 diabetes drug, liraglutide (Victoza, Novo Nordisk), has an FDA-approved indication for reducing the risk for MI, stroke, and cardiovascular death, but it is not an SGLT2 inhibitor and it is taken by injection, not orally.
The new indication for canagliflozin also applies to the fixed-dose combinations of canagliflozin/metformin (Invokamet) and canagliflozin/metformin extended-release (Invokamet XR) tablets.
As previously reported by Medscape Medical News, the Canagliflozin Cardiovascular Assessment Study (CANVAS) evaluated the effect of the SGLT2 inhibitor on CV risk in a broad population of more than 10,000 adults with type 2 diabetes with or at risk for CVD.
In the overall population, treatment with canagliflozin (as compared with placebo) plus standard of care reduced the combined risk of MI, stroke, and CV death by 14% (hazard ratio [HR], 0.86; 95% CI, 0.75 - 0.97; P < .0001 for noninferiority, P = .0158 for superiority).
In patients with CVD, treatment with canagliflozin reduced the combined risk of MI, stroke, and CV death by 18% compared with placebo (HR, 0.82; 95% CI, 0.72 - 0.95).
"Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes," said Ralph DeFronzo, MD, chief of the Division of Diabetes at University of Texas, Health Diabetes Center, San Antonio, in the Janssen release.
"With this approval, Invokana now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events," said DeFronzo.
As with other SGLT2 inhibitors, canagliflozin may increase the risk of lower-limb amputations. The FDA added a boxed warning to the canagliflozin label last year.
Full prescribing information and a medication guide for canagliflozin are available online.
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Cite this: Canagliflozin (Invokana) Gets FDA Nod for CV Protection - Medscape - Oct 31, 2018.
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