Forxiga recommended for approval in the EU for heart failure
Official approval has been sought to make Forxiga (dapagliflozin) the first sodium-glucose co-transporter-2 (SGLT2) inhibitor available to treat people with chronic heart failure in Europe.
The AstraZeneca drug has been recommended for an indication extension of its marketing authorisation in the European Union (EU).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the SGLT2 drug for the treatment of symptomatic chronic heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes.
Dapagliflozin is a major and welcome breakthrough with the potential to improve not only the quality, but also importantly, the length of life for millions of people suffering from this terrible disease in Europe and throughout the world Professor John McMurray
If approved, oral Forxiga will become the first sodium-glucose co-transporter-2 (SGLT2) inhibitor indicated for treating HFrEF.
It is also hoped that by administering the drug to people who may be at risk, it could help reduce the number of hospital admissions, helping to relieve beds and staff amid the COVID-19 pandemic.
The recommendation comes off the back of the Phase III Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure (DAPA-HF) trial.
The international, multi-centre, parallel-group, randomised, double-blinded trial showed that Forxiga reduced the risk of cardiovascular (CV) death or worsening of HF events versus placebo by 26 per cent.
A total of 4,744 people with HFrEF, with and without type 2 diabetes, took part in the study, allowing researchers to analyse the effect of what a daily dose of 10mg Forxiga has on people, when compared to placebo in addition to standard of care.
Professor John McMurray, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, said: “I am delighted that we may soon have a new treatment that is effective, safe and simple to use for patients with heart failure with reduced ejection fraction.
“Dapagliflozin is a major and welcome breakthrough with the potential to improve not only the quality, but also importantly, the length of life for millions of people suffering from this terrible disease in Europe and throughout the world.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “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.”