EU updates dapagliflozin label to include CV outcomes data

August 16, 2019 0 By FM

The European Commission has approved an update to the marketing authorisation for dapagliflozin (Forxiga) to include positive cardiovascular (CV) outcomes and renal data from the phase III trial.

Dapagliflozin is an oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control.

“For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before a heart attack or stroke,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, Astra Zeneca, in a company release.

In the phase III DECLARE-TIMI 58 trial, dapagliflozin 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.

Inclusion of the trial data to the medicine’s label is currently under regulatory review in the US and China.

DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is the largest CV outcomes trial conducted for a selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) to date in a broad patient population, said AstraZeneca.

The randomised, double-blinded, placebo-controlled, multicentre trial, designed to evaluate the effect of dapagliflozin compared with placebo on CV outcomes in adults with T2D at risk of CV events, included more than 17,000 patients across 882 sites in 33 countries.