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CHMP of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended a change to the European marketing authorization for AstraZeneca’s Forxiga (dapagliflozin) in patients with Type-2 diabetes.
In a July 1, 2019 press release, AstraZeneca announced the positive opinion from the CHMP, which has been made as a result of the cardiovascular outcomes data from the Phase III DECLARE-TIMI 58 trial. The trial, which included more than 17,000 patients, demonstrated that a statistically-significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death versus placebo was achieved in patients treated with Forxiga.
“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 benefit from this medicine,” stated Mene Pangalos, executive vice-president, BioPharmaceuticals R&D in the press release.
Additionally, AstraZeneca has announced that regulatory reviews and submissions are ongoing in other countries, including the United States, China, and Japan.