NICE RECOMMENDS FORXIGA (dapagliflozin) FOR THE TREATMENT OF SYMPTOMATIC CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN ADULTS

• Dapagliflozin is the first SGLT2 inhibitor recommended by NICE as an option for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), as an add-on to optimised standard care.
• Almost one million people are living with heart failure (HF) in the UK, of those, approximately 250,000 patients in England and Wales could be eligible for treatment.
• HF is the cause of approximately 65,000 unplanned hospital admissions per year and the risk of death associated with HF is worse than some of the most common cancers.

Luton, UK, Thursday 24 December 2020 – AstraZeneca today announced that the National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending dapagliflozin as an option for treatment of symptomatic chronic heart failure (HF) with reduced ejection fraction (HFrEF) in adults, as an add-on to optimised standard care. NICE recommends that treatment is started on the advice of a heart failure specialist, and that monitoring should be done by the most appropriate healthcare professional. Dapagliflozin is in a class of medicines called SGLT2 inhibitors, and is the first medicine of this kind to be licensed and recommended for use in HF. In the DAPA-HF clinical trial, dapagliflozin, on top of standard of care, reduced the risk of cardiovascular (CV) death, being hospitalised by HF or needing an urgent visit to hospital for HF by 26% (relative risk reduction [RRR], absolute risk reduction [ARR] = 4.9%), when compared to placebo (hazard ratio [HR] = 0.74 [95% confidence interval {CI} 0.65-0.85]; p < 0.001) ([16.3% vs 21.2% patients with event, respectively]). The trial data showed that for every 21 patients treated with dapagliflozin, one CV-related death, urgent visit to hospital for HF, or hospitalisation for HF could be avoided. The overall safety profile of dapagliflozin in patients with heart failure was consistent with the known safety profile of dapagliflozin.

John McMurray, MD, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: “This is great news for people with heart failure with reduced ejection fraction, as they will now be able to receive a completely novel treatment for their condition, which, when added to existing therapy, improves symptoms, reduces the need for hospital admission and increases survival. Dapagliflozin can make a huge difference for those suffering from this life-restricting and life-threatening condition.” HF is a life-threatening, chronic condition where a person’s heart is unable pump enough blood around their body. Almost one million people are living with HF in the UK, and the risk of death associated with HF is worse than some of the most common cancers. HF is also the cause of approximately 65,000 unplanned hospital admissions per year, and with COVID-19 placing such a large burden on the health system, it is critical that heart failure patients have access to care options to help them reduce the risk of their symptoms worsening and need for admission to hospital.

Nick Hartshorne-Evans, CEO of the Pumping Marvellous Foundation, said: “Despite the high mortality risk for people living with heart failure in the UK and the dramatic impact on their quality of life as a whole, the condition is often under-recognised and misdiagnosed. COVID-19 has also placed greater strain on both people living with the condition and healthcare services. This has highlighted a clear and urgent need for multiple treatment options that minimise contact with healthcare professionals. We are therefore pleased with NICE’s decision to provide access through both GP care settings on the advice of specialists and hospitals. This will support better health outcomes and reduce the risk of people living with heart failure needing to be hospitalised, which is critical during this pandemic.”

This recommendation is based on the positive results from the landmark DAPA-HF Phase III trial, published in The New England Journal of Medicine. It follows approval for use in adults with symptomatic chronic heart failure with reduced ejection fraction from the European Commission (EC) in November 2020.

Tom Keith-Roach, President, AstraZeneca UK, said: “This final NICE recommendation is exciting news for people living with heart failure, with and without type-2 diabetes. Importantly, primary care physicians will be able to prescribe dapagliflozin in heart failure following agreement with a heart failure specialist. This treatment has the potential to improve symptoms and extend the lives of hundreds of thousands of people in the UK. Working closely with our partners in the NHS, we are determined to help eradicate heart failure as one of the leading causes of hospitalisation and death in this country.”

The very common adverse event associated with dapagliflozin in placebo-controlled clinical studies and post-marketing experience is hypoglycaemia (when used with sulphonylurea or insulin). Common associated adverse events are genital infections, urinary tract infections, dizziness, rash, back pain, dysuria, polyuria, haematocrit increased, creatinine renal clearance decreased during initial treatment and dyslipidaemia.

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CONTACTS
UK Media Enquiries
Tatiana Allan, AstraZeneca: 07385 037254 / tatiana.allan@astrazeneca.com
Alex Larkinson, Edelman: 07980 687255 / alex.larkinson@edelman.com

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