The EU approval of Forxiga was based on data from the international, multi-centre, parallel-group, randomised and double-blinded DAPA-HF phase III trial.
AstraZeneca claims that Forxiga is the first sodium-glucose co-transporter-2 (SGLT2) inhibitor that demonstrated a statistically significant reduction in the risk of the composite of cardiovascular (CV) death or worsening of HF events, including hospitalisation for HF (hHF).
The DAPA-HF phase III trial showed that Forxiga minimised the risk of the composite outcome compared to placebo by 26% and both components of the primary composite endpoint contributed benefit to the overall effect.
The DAPA-HF study recruited 4,744 patients with heart failure and reduced ejection fraction, with and without T2D, to assess the effect of Forxiga 10mg compared to placebo.
AstraZeneca already secured FDA approval in the US for Forxiga (called Farxiga in the US) to treat patients with HFrEF. It is currently under assessment in Japan and various other countries across the world.
AstraZeneca R&D biopharmaceuticals executive vice president Mene Pangalos said: “With this approval of Forxiga, we can redefine the standard of care for millions of people in the EU living with heart failure.
“We are another step closer to achieving our ambition of preventing or treating heart failure by providing a treatment that can significantly reduce cardiovascular death and hospitalisation.”
Forxiga is also designated to treat adults with insufficiently controlled T2D as both monotherapy and as part of combination therapy as an adjunct to diet and exercise to improve glycaemic control.
It is currently being tested for patients with HF in the DELIVER and DETERMINE phase III trials. In addition, Forxiga will be assessed in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial.