Forxiga label updated in EU in type-2 diabetes

European Commission approves update to marketing authorisation for Forxiga

The European Commission has approved an update to the marketing authorisation for AstraZeneca’s 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.

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.

For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke.

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.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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.”

Inclusion of the DECLARE-TIMI 58 trial data to the medicine’s label is currently under regulatory review in the US and China.