Green Light for CVD Data From DECLARE in Dapagliflozin EU Label


July 02, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion regarding a requested label update in the EU for the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin (Forxiga, AstraZeneca) for the treatment of patients with type 2 diabetes to include cardiovascular (CV) outcomes data from the DECLARE-TIMI 58 trial, according to a statement from the company.

Once the change is approved — normally a formality within about 60 days — the EU label for dapagliflozin will be in line with those of two other SGLT2 inhibitors, empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) and canagliflozin (Invokana, Janssen) for type 2 diabetes.

The labels for these two agents were updated to include positive CV outcomes data from the EMPA-REG OUTCOME study in December 2016 and the CANVAS trial in September 2018, respectively.

A broad population of patients with type 2 diabetes were enrolled in DECLARE-TIMI 58, including 10,000 without pre-existing cardiovascular disease (CVD) but with multiple risk factors, as well as 7000 patients with pre-existing CVD. The results were first reported at the American Heart Association (AHA) Scientific Sessions 2018 in November last year and simultaneously published in the New England Journal of Medicine.

Dapagliflozin achieved a significant reduction in the composite endpoint of hospitalization for heart failure or CV death versus placebo, one of two primary efficacy endpoints. There were fewer major adverse cardiac events (MACE) observed with dapagliflozin, the other primary efficacy endpoint; however, this did not reach statistical significance.

The DECLARE-TIMI 58 results were similar to those of EMPA-REG OUTCOME and CANVAS — with a significant reduction in heart failure hospitalization and renal events with the SGLT2 inhibitors compared with placebo. 

And DECLARE-TIMI 58 "showed no imbalance with dapagliflozin versus placebo in terms of amputations, fractures, bladder cancer, or Fournier's gangrene," notes AstraZeneca.

Regulatory reviews and submissions to update the dapagliflozin label with data from DECLARE-TIMI 58 are ongoing in several countries, including the United States, China, and Japan, the company adds.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and on Facebook.


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