AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke. In the Phase III DECLARE-TIMI 58 trial, Forxiga reduced the composite endpoint of hospitalisation 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 EU.”
In the Phase III DECLARE-TIMI 58 trial, Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints. There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however this did not reach statistical significance.
The Phase III DECLARE-TIMI 58 trial confirmed the well-established safety profile of Forxiga. The trial showed no significant imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier’s gangrene.
Inclusion of the DECLARE-TIMI 58 trial data to the medicine’s label is currently under regulatory review in the US and China