AstraZeneca’s Forxiga approved in EU to treat chronic heart failure
The European Commission has approved Forxiga (dapagliflozin) for use in the EU to treat symptomatic chronic heart failure with reduced ejection fraction.
AstraZeneca’s Forxiga (dapagliflozin) has been approved in the EU for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The approval by the European Commission (EC) is based on positive results from the DAPA-HF Phase III trial. The trial was an international, multi-centre, parallel-group, randomised, double-blinded study in 4,744 patients with heart failure and reduced ejection fraction. The clinical trial showed that the drug met all its primary and secondary endpoints, demonstrating its efficacy. Forxiga is a first-in-class, oral, once-daily sodium-glucose co-transporter-2 (SGLT2) inhibitor.
According to the company, Forxiga is the first inhibitor to have shown a statistically significant reduction in the risk of the composite of cardiovascular death or worsening of heart failure events, including hospitalisation. The DAPA-HF Phase III trial demonstrated that Forxiga, in addition to standard-of-care, reduced the risk of the composite outcome versus placebo by 26 percent and both components of the primary composite endpoint contributed benefit to the overall effect. In the DAPA-HF Phase III trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine. During the trial, the researchers found that one cardiovascular death or hospitalisation for heart failure or an urgent visit associated with heart failure could be avoided for every 21 patients treated.
Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D, 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.”