Forxiga label updated with CV data

The AstraZeneca (LSE: AZN) type two diabetes drug Foxiga (dapagliflozin) has had its label updated for the European Union (EU) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial.

In the study, Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalization for heart failure or CV death versus placebo, one of the two primary efficacy endpoints, although the reduction in CV events was not statistically significant SGLT2, the other primary efficacy endpoint.

AstraZeneca’s Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “For patients with type two diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke. We look forward to bringing these additional benefits of the medicine to people with type-2 diabetes in the EU.”