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.
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.
If approved, Forxiga would become the first SGLT2 inhibitor indicated for heart failure with reduced ejection fraction in patients with and without type-2 diabetes.
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.
“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,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.