First oral diabetes drug to win this indication
The SGLT2 inhibitor canagliflozin (Invokana) was given the green light by the FDA for the prevention of myocardial infarction, stroke, and death among patients with type 2 diabetes who have established cardiovascular disease, Janssen announced.
First approved in 2013 as a boost to diet and exercise for glycemic control in diabetes, the drug won the expanded indication based on the 10,000-person CANVAS trial that showed the cardiovascular benefits of canagliflozin in a population with type 2 diabetes that either had established cardiovascular disease or had two or more risk factors for it.
The newly approved indication also applies to the fixed-dose combinations of canagliflozin/metformin HCl (Invokamet) and canagliflozin/metformin HCl extended-release (Invokamet XR).
"This FDA approval makes Invokana the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke, or cardiovascular death," said a company representative in a statement. "Not only does Invokana enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events."
SGLT2 inhibitors have also been tied to a reduced risk of heart failure in patients with type 2 diabetes, although this is not yet an approved indication for these drugs.
Noted side effects of canagliflozin include the risk of amputation and dehydration. The FDA also recently warned that necrotizing fasciitis of the perineum was associated with SGLT2 inhibitor treatment.
Canagliflozin is not the first diabetes drug per se to be made available for cardiovascular prevention -- in 2017, U.S. regulators approved the injectable diabetes drug liraglutide(Victoza) for this indication.
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Read the original article on Medpage Today: FDA Clears Invokana for CV Prevention in T2D