AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union (EU) for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type-2 diabetes (T2D).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine.
Forxiga is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of cardiovascular (CV) death or worsening of HF events (including hospitalisation for HF, hHF) versus placebo where 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.
“The unmet need for novel medicines in heart failure remains high, with more than half of patients expected to die within five years of diagnosis.Novel treatment options reducing cardiovascular death and hospitalisation, in addition to improving symptoms, are urgently needed. With the positive opinion for Forxiga we are one step closer to transforming the standard of care for millions of people in the EU living with heart failure,” says Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.
The CHMP recommendation states Forxiga is indicated in adults for the treatment of symptomatic chronic HFrEF.
Forxiga (known as Farxiga in the US) is approved by the US Food and Drug Administration (FDA), as well as in several other countries around the world, for the for the treatment of patients with HFrEF.
Forxiga is evolving cardiorenal prevention as science continues to identify the underlying links between the heart, kidneys and pancreas. DAPA-HF is part of DapaCare, a robust clinical trial programme to assess the potential CV and renal benefits of Forxiga, including the DECLARE-TIMI 58 trial which first evaluated Forxiga for the treatment of hHF and CV risk factors in patients with T2D. The programme has also explored the treatment of patients with chronic kidney disease (CKD) in the ground-breaking DAPA-CKD Phase III trial and is also currently being tested for HF patients with preserved ejection fraction (HFpEF) in the DELIVER Phase III trial with data anticipated in the second half of 2021.
Photo of Mene Pangalos: AstraZeneca