AstraZeneca’s Forxiga (dapagliflozin), has been approved by the European Commission (EC). It is now available for chronic kidney disease (CKD), in adults with or without type-2 diabetes (T2D), in the EU. Forxiga is the first adult CDK therapy to be approved in the UK and EU for more than 20 years.
Forxiga is an oral once-daily inhibitor of sodium-glucose cotransporter 2, (SGLT2)
Pharmafile reported that the latest approval was received in conjunction with a license extension from UK Medicines and Healthcare products Regulatory Agency.
The positive data from Phase III DAPACKD clinical trial of dapagliflozin was the basis for approval by the EC.
This trial data showed that Farxiga, along with standard-of-care (SoC), therapy, provided a 39% decrease in the relative risk for renal function worsening, end-stage kidney disease onset, or cardiovascular or renal deaths risk, compared to placebo in stages 2-4 CKD with high urinary albumin excretion.
The primary goal of the trial was to reduce the relative risk. An angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker were administered as the SoC treatment.
The drug also reduced the relative mortality risk due to any cause by 31%, compared with placebo.
Forxiga’s safety record and tolerance in the trial was in line with the drug’s already established safety profile.
Mene Pangalos,Mene PangalosBioPharmaceuticals R&D executive Vice-President, stated that “Today’s approval is an important milestone in Forxiga and has potential to transform the treatment of millions of EU citizens with chronic kidney disease.”
“While Forxiga and other new medicines are a step forward in medical care, we also believe that early detection and prevention is key to preventing this life-threatening and debilitating disease.”
Farxiga was approved by the US Food and Drug Administration (FDA), May for the treatment of CKD in patients at risk.
This drug is currently being evaluated in Japan and other countries for this patient population.
AstraZeneca reported that the European Medicines Agency (EC) gave a positive opinion on the drug for CKD after the drug was approved.
