Posted by Michael Wonder on 05 Aug 2019
Forxiga label updated in the EU in type 2 diabetes mellitus
5 August 2019 - Label updated with positive cardiovascular outcomes and renal data from the DECLARE-TIMI 58 trial
AstraZeneca today announced that the European Commission has approved an update to the marketing authorisation for Forxiga (dapagliflozin) to include positive cardiovascular outcomes and renal data from the Phase III DECLARE-TIMI 58 trial in adults with type 2 diabetes mellitus. The trial enrolled a majority of patients with no existing cardiovascular disease.
