First new adult CDK treatment in 20 years gains UK and EU approval

pharmafile | August 9, 2021 | News story | Medical Communications, Research and Development, Sales and Marketing  

AstraZeneca has announced the EU approval of Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, alongside a licence extension from the MHRA.

The decision is based on positive data from the Phase III DAPA-CKD trial which demonstrated that dapagliflozin, in addition to standard care, was the first medicine to show a significant reduction in all-cause mortality in a renal outcomes trial in patients with chronic kidney disease with and without type-2 diabetes.

Professor David Wheeler, Professor of Kidney Medicine at University College London, said: “This decision is a significant milestone for people living with chronic kidney disease. It provides healthcare professionals with an effective new option that can slow progression of disease and possibly delay the need for dialysis. As a clinician, I am thrilled to see advances like this, which have the potential to transform the experiences of many of the people living with this condition.”

CKD is a long-term condition where the kidneys do not work as well as they should and are unable to remove waste products from the body.  Currently, an estimated 3.5 million people in the UK have CKD and it is estimated up to 1.2 million of these people are living with the condition undiagnosed. This is particularly relevant in Black, Asian, and minority ethnic communities, as they are five times more likely to develop CKD that other groups.

The co-chair of the DAPA-CKD trial and its executive committee, Prof. Hiddo L Heerspink, University Medical Center Groningen in the Netherlands, said: “Today’s approval establishes dapagliflozin as the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status in the EU. Based on the unprecedented results from the DAPA-CKD Phase III trial, dapagliflozin delays disease progression providing physicians a critical opportunity to improve the prognosis of patients with chronic kidney disease.”

The Phase III trial demonstrated that Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the relative risk of worsening of renal function, onset of end-stage kidney disease, or risk of cardiovascular or renal death by 39% (the primary composite endpoint), compared to placebo in patients with CKD Stages 2-4 and elevated urinary albumin excretion.

Forxiga also significantly reduced the relative risk of death from any cause by 31% compared to placebo.

Tom Keith-Roach, President of AstraZeneca UK, said: “Today’s approval of dapagliflozin marks a significant advancement in the treatment of chronic kidney disease for people with and without diabetes, becoming the first new treatment indicated for adults with CKD in nearly 20 years.

“Dapagliflozin demonstrated significant reductions in progression to end stage renal disease, hospitalisations, and death in CKD, and has the potential to make a difference to the lives of many of the people living with this condition. There is now an urgent need to work with the clinical community to diagnose CKD earlier and to ensure patients have access to a medicine that prevents disease progression and premature death.”

Kat Jenkins

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