Forxiga receives approval in the European Union for treating CKD

By Patrick Miller |

Forxiga (dapagliflozin), a SGLT2 (sodium-glucose cotransporter 2) inhibitor developed by AstraZeneca, has reportedly been approved for use in the European Union (EU). The drug has obtained approval for the treatment of CKD (chronic kidney disease) in adults – both, with and without T2D (Type-2 diabetes).

The European Commission has apparently approved the drug on the basis of positive results from the DAPA-CKD Phase III trial. The Committee for Medicinal Products for Human Use of the European Medicines Agency had also provided a recommendation for the same.

The results of the DAPA-CKD Phase III trial state that Forxiga, in tandem with the standard-of-care (SoC) treatment (usually with an angiotensin receptor blocker or an angiotensin-converting enzyme inhibitor), relatively reduces the risk of end-stage kidney disease (ESKD) onset, deteriorating renal function, or risk of renal or cardiovascular (CV) death by 39% (the primary composite endpoint), as opposed to the placebo effect, in patients suffering from CKD (Stages 2-4).

Prof. Hiddo L. Heerspink, University Medical Center Groningen, the Netherlands, and the Co-chairperson, DAPA-CKD Phase III trial, has been reported to state that the approval establishes Forxiga as the first SGLT2 inhibitor to be cleared for treating chronic kidney disease, irrespective of the diabetes status in the European Union. The results from the DAPA-CKD Phase III trial demonstrate that dapagliflozin provides physicians the critical opportunity to improve CKD patient prognosis, thereby helping to delay disease progression, Prof. Hiddo L. Heerspink further added.

According to a statement by Mene Pangalos, Executive VP, BioPharmaceuticals R&D, the approval of Forxiga is an important milestone and has the potential to be a path-breaking treatment for people afflicted with chronic kidney disease in the EU. Novel drugs such as Forxiga will certainly help advance the standard of care, however, the company is also committed to preventing and detecting this debilitating disease as early as possible, Mene Pangalos added.



Source Credits:

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/forxiga-approved-in-the-eu-for-ckd.html

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