AstraZeneca Plc (LON:AZN), a global, science-led biopharmaceutical company, announced on Monday the approval by the European Commission of 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).

This trial enrolled a majority of patients with no existing cardiovascular disease.

The company stated that 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. 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.

Also, there were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however this did not reach statistical significance.

According to the company, 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.

In addition, inclusion of the DECLARE-TIMI 58 trial data to the medicine's label is currently under regulatory review in the US and China.

AstraZeneca is focussed on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism, and Respiratory.