UK licence extension approved for AstraZeneca’s dapagliflozin

MHRA

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a licence extension for dapagliflozin for the treatment of symptomatic chronic heart failure (HF). 

The drug is approved in patients with HF and a left ventricular ejection fraction (LVEF) >40%, including HF with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). 

HF is a life-threatening chronic disease in which the heart cannot pump enough blood around the body, affecting almost one million people in the UK.  

There are three main categories of HF related to ejection fraction (EF), a measurement of the percentage of blood leaving the heart each time it contracts. Approximately 59% of all HF patients have mildly reduced or preserved EF with few therapeutic options available. 

John McMurray, Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK, said: “Dapagliflozin has been clinically shown to reduce hospitalisations and cardiovascular deaths in heart failure and as a clinician, I’m pleased to see this decision that will bring us closer to addressing the full spectrum of heart failure and reducing the significant disease burden in Great Britain.” 

Dapagliflozin is already approved in Great Britain for the treatment of insufficiently controlled type 2 diabetes (T2D), symptomatic chronic HFrEF and chronic kidney disease (CKD). 

Phase III trial results

The decision from the MHRA was based on results from the DELIVER Phase III trial, which showed that dapagliflozin met its primary endpoint in reducing the composite outcome of cardiovascular (CV) death or worsening HF by 18% (16.4% in the dapagliflozin group and 19.5% in the placebo group over a median follow-up of 2.3 years. 

Additionally, the pooled analysis of the DELIVER and DAPA-HF Phase III trials demonstrated that dapagliflozin reduced the risk of CV death by 14% over the median follow-up of 22 months, hospitalisation for HF by 29%, and death from CV causes by 10%. 

Ed Piper, Medical and Scientific Affairs Director, AstraZeneca UK, said: “We’re delighted that the MHRA has authorised dapagliflozin for use in heart failure with preserved ejection fraction. We continue to work with NICE and the SMC to ensure that patients living with heart failure can access dapagliflozin as quickly as possible.” 

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