NICE recommends AstraZeneca’s FORXIGA for heart failure

pharmafile | January 7, 2021 | News story | |  AstraZeneca, NICE 

NICE has issued a positive Final Appraisal Document (FAD) recommending AstraZeneca’s FORXIGA (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.

The regulatory body 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% when compared with placebo.

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 the drug.

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.

Tom Keith-Roach, President of 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.”

Darcy Jimenez

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