EU approves Forxiga for chronic kidney disease

The approval by the European Commission is based on positive results from the DAPA-CKD Phase III trial. The decision follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

The DAPA-CKD Phase III trial demonstrated that Forxiga, on top of standard-of-care (SoC) 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 (ESKD), or risk of cardiovascular (CV) or renal death by 39% (the primary composite endpoint), compared to placebo (absolute risk reduction [ARR]=5.3%, p<0.0001) in patients with ckd stages 2-4 and elevated urinary albumin excretion.></0.0001)>

Forxiga also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo. The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.