Forxiga receives positive EU CHMP opinion for DECLARE-TIMI 58 cardiovascular outcomes data
AstraZeneca today 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 Phase III DECLARE-TIMI 58 trial.Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are pleased with this positive opinion for the cardiovascular outcomes and renal data for Forxiga and this recommendation acknowledges that even more people with type-2 diabetes could