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Forxiga label updated in the EU in type-2 diabetes
Forxiga label updated in the EU in type-2 diabetes.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 8660H AstraZeneca PLC 05 August 2019 \n\n5 August 2019 07:00 BST\n \nForxiga label updated in the EU in type-2 diabetes\n \nLabel updated with positive cardiovascular outcomes and renal data from the DECLARE-TIMI 58 trial\n \nAstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular (CV) outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type-2 diabetes (T2D). The trial enrolled a majority of patients with no existing cardiovascular disease.\n \nMene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: \"For patients with type-2 diabetes, heart failure is one of the earliest cardiovascular complications before heart attack or stroke. In the Phase III DECLARE-TIMI 58 trial, Forxiga reduced the composite endpoint of hospitalisation for heart failure or cardiovascular death in patients with type-2 diabetes, and we look forward to bringing these additional benefits of the medicine to people with type-2 diabetes in the EU.\"\n \nIn the Phase III DECLARE-TIMI 58 trial, 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.\n \nThe Phase III DECLARE-TIMI 58 trial confirmed the well-established safety profile of Forxiga. The trial showed no significant imbalance with Forxiga versus placebo in amputations, fractures, bladder cancer or Fournier's gangrene.\n \nInclusion of the DECLARE-TIMI 58 trial data to the medicine's label is currently under regulatory review in the US and China.\n \nAbout DECLARE-TIMI 58\nDECLARE (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. It is an AstraZeneca-sponsored, Phase III, randomised, double-blinded, placebo-controlled, multicentre trial, designed to evalua...