Forxiga ( Dapagliflozin ) has been approved in the European Union ( EU ) for the treatment of symptomatic chronic heart failure ( HF ) with reduced ejection fraction ( HFrEF ) in adults with and without type-2 diabetes ( T2D ).
The approval by the European Commission is based on results from the landmark DAPA-HF trial, published in The New England Journal of Medicine ( NEJM ).
It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency ( EMA ).
Forxiga is the first sodium-glucose co-transporter-2 ( SGLT2 ) 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 for heart failure.
The DAPA-HF trial has demonstrated that Forxiga, in addition to standard of care, reduced the risk of the composite outcome versus placebo by 26% and both components of the primary composite endpoint contributed benefit to the overall effect.
In the DAPA-HF trial, the safety profile of Forxiga was consistent with the well-established safety profile of the medicine.
During the trial, one cardiovascular death or hospitalisation for heart failure or an urgent visit associated with heart failure could be avoided for every 21 patients treated.
Heart failure affects approximately 64 million people worldwide ( at least half of whom have a reduced ejection fraction ), including 15 million in the EU and six million in the US.
It is a chronic disease where half of patients will die within five years of diagnosis.
There are two main categories of heart failure related to ejection fraction ( EF ), a measurement of the percentage of blood leaving the heart each time it contracts: HFrEF and HFpEF.
HFrEF occurs when the left ventricle muscle is not able to contract adequately and therefore, expels less oxygen-rich blood in to the body.
Heart failure is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden.
DAPA-HF ( Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure ) is an international, multi-centre, parallel-group, randomised, double-blinded trial in 4,744 patients with heart failure and reduced ejection fraction ( LVEF less than or equal to 40% ), with and without type-2 diabetes, designed to evaluate the effect of Dapagliflozin 10mg, compared with placebo, given once daily in addition to standard of care.
The primary composite endpoint was time to the first occurrence of a worsening heart failure event ( hospitalisation or equivalent event; i.e. an urgent heart failure visit ), or cardiovascular death.
The median duration of follow-up was 18.2 months. ( Xagena )
Source: AstraZeneca, 2020