Forxiga recommended for approval in the EU by CHMP for the treatment of patients with chronic kidney disease – AstraZeneca
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the DAPA-CKD Phase III trial that showed Forxiga, on top of standard-of-care treatment with an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function, end-stage kidney disease (ESKD) and cardiovascular (CV) or renal death, compared to placebo. Forxiga also significantly reduced the risk of death from any cause, compared to placebo. In the trial, the safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.