Forxiga gains new European approval for CKD

Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D), said UK pharma major AstraZeneca (LSE: AZN).

The approval by the European Commission is based on positive results from the DAPA-CKD Phase III trial. The decision follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency, further cementing its lead against Eli Lilly (NYSE: LLY) and Boehringer Ingelheim’s SGLT2 rival Jardiance (empagliflozin), which is not expecting data from its kidney disease outcomes trial until 2022.

Farxiga was first approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D in 2019, and then for the treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults regardless of diabetes status in May last year. The drug generated second-quarter 2021 sales of $734 million, up 65% on the like year-earlier quarter.