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 .
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 -- .
The trial included type 2 diabetes patients who had atherosclerotic cardiovascular disease or multiple risk factors: age 55+ for men or 60 for women and hypertension, dyslipidemia, use of tobacco, or a combination thereof.
Dapagliflozin is also on the FDA's Fast Track for review of a broader heart failure indication.
Dapagliflozin scored a big win last month in the DAPA-HF trial, lowering the risk of cardiovascular death and decompensation and improving symptoms in HF with reduced ejection fraction (HFrEF), regardless of type 2 diabetes status.
The accelerated review includes reduction in risk of cardiovascular death or worsening of heart failure in not only adults with HFrEF but also in those with preserved ejection fraction, based on the slated for completion in 2021.
Dapagliflozin is also fast tracked for review of an indication in delaying progression of renal failure and preventing cardiovascular and renal death in patients with chronic kidney disease, based on the DAPA-CKD trial slated for completion late in 2020.
The drug does not have an indication in reducing incidence of HF, cardiovascular death, or kidney disease.