This article is more than 5 years old. Information may no longer be current.
European Commission approves updated CV, renal marketing information for dapagliflozin
The European Commission approved updated marketing information for use of dapagliflozin for treatment of type 2 diabetes to include positive cardiovascular and renal data from the DECLARE-TIMI 58 trial, according to a press release from AstraZeneca.
“For patients with type 2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke,” said Mene Pangalos, executive vice president of biopharmaceuticals research and development at AstraZeneca. “In the phase 3 DECLARE-TIMI 58 trial, Forxiga reduced the composite endpoint of hospitalization for heart failure or cardiovascular death in patients with type 2 diabetes, and we look forward to bringing these additional benefits of the medicine to people with type 2 diabetes in the [European Union].”
As Endocrine Today previously reported, results from DECLARE-TIMI 58 demonstrated numerous benefits of the SGLT2 inhibitor for patients with type 2 diabetes, including potential for kidney disease prevention and reduction of heart failure risk.
Indications for dapagliflozin, marketed as Forxiga in Europe and Farxiga in the U.S., are out of step in the two regions. In February, the FDA approved an expanded indication for dapagliflozin, based on the DERIVE study, for use in patients with type 2 diabetes and moderate renal impairment. The agency is still reviewing the CV data from DECLARE-TIMI 58, according to AstraZeneca. In March, the European Commission approved the use of dapagliflozin in conjunction with insulin for treatment of type 1 diabetes. The FDA in July rejected an indication for type 1 diabetes. – by Phil Neuffer