AstraZeneca’s Forxiga gets EMA positive opinion for DECLARE-TIMI 58 cardiovascular outcomes data

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 hase III DECLARE-TIMI 58 trial.

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.

Forxiga (dapagliflozin) is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporte 2 (SGLT2) indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood-pressure reduction, as an adjunct to diet and exercise in adults with T2D. Forxiga has a robust programme of clinical trials that includes more than 35 completed and ongoing Phase IIb/III trials in more than 35,000 patients, as well as more than 1.8 million patient-years’ experience.