Farxiga Approved to Cut HF Admission Risk in T2D
Does approval for high-risk patients presage a broader heart failure indication?
The FDA approved dapagliflozin (Farxiga) to reduce heart failure (HF) hospitalization risk in adults with type 2 diabetes at elevated risk due to established cardiovascular disease or multiple risk factors for it, AstraZeneca announced.
Dapagliflozin is the first selective inhibitor of sodium-glucose cotransporter 2 (SGLT2) to gain that particular supplemental indication.
Just last month, SGLT2 inhibitor canagliflozin (Invokana) got an indication to reduce HF admissions and other cardiovascular events among type 2 diabetes patients with diabetic kidney disease.
Dapagliflozin's new indication was based on the DECLARE-TIMI 58 trial. Although the trial missed the primary endpoint for major adverse cardiovascular events, it met the other by reducing risk of cardiovascular death or hospitalization for heart failure by 17% versus placebo -- driven entirely by HF admission reduction./.../
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