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, AstraZeneca has announced today.
The update applies to adults with type II diabetes, and was decided after the drug 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 in the trial.
The data also confirmed the well-established safety profile of the treatment, with no significant imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier’s gangrene.
The first-in-class, oral once-daily SGLT2 inhibitor is currently indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, explained that for patients with the disorder, “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 II diabetes, and we look forward to bringing these additional benefits of the medicine to people with type II diabetes in the EU.”
The news comes weeks after the drug was hit with a complete response letter by the US Food and Drug Administration (FDA), regarding a supplemental New Drug Application.