AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study.
First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney disease.
AstraZeneca now says that data from the DELIVER and DAPA-HF Phase 3 studies show its efficacy in heart failure regardless of ejection fraction.
In the two studies, the safety profile of Farxiga was consistent with prior data.
Farxiga’s biggest competitor is Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly, first approved in 2014 for type 2 diabetes. Jardiance now has two FDA indications related to heart failure.
Another competitor is the heart failure drug Entresto (sacubitril/valsartan) from Novartis, which had $2.8 billion in sales in …