(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) announced Monday that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended Forxiga (dapagliflozin) for an indication extension of its marketing authorisation in the European Union.
The recommendation is for the treatment of symptomatic chronic heart failure with reduced ejection fraction or HFrEF in adults with and without type-2 diabetes or T2D.
Heart failure or HF is a life-threatening chronic disease in which the heart cannot pump enough blood around the body, affecting 15 million people in the EU, at least half of which have a reduced ejection fraction.
The CHMP based its positive opinion on results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine.
The DAPA-HF Phase III trial demonstrated that Forxiga, in addition to standard of care, reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26%.
During the trial, one CV death or hHF or an urgent visit associated with HF could be avoided for every 21 patients treated.
The company noted that Forxiga is the first SGLT2 inhibitor to have shown a statistically significant reduction in the risk of cardiovascular or CV death or worsening of HF events 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 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, as well as in several other countries around the world, for the for the treatment of patients with HFrEF.
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