AstraZeneca announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a change to the European marketing authorisation for Forxiga (dapagliflozin) in patients with type-2 diabetes (T2D) to include cardiovascular (CV) outcomes data from the Phase III DECLARE-TIMI 58 trial.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
“We are pleased with this positive opinion for the cardiovascular outcomes and renal data for Forxiga and this recommendation acknowledges that even more people with type-2 diabetes could benefit from this medicine.”
In DECLARE-TIMI 58, the largest and broadest CV outcomes trial conducted for a SGLT2 inhibitor to date, Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or CV death versus placebo, one of the two primary efficacy endpoints. There were fewer major adverse CV events observed with Forxiga for the other primary efficacy endpoint, however this did not reach statistical significance.
DECLARE-TIMI 58 confirmed the well-established safety profile of Forxiga. The trial showed no imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier’s gangrene.
Regulatory reviews and submissions are ongoing in several countries, including the US, China and Japan.