Posted by Michael Wonder on 19 Oct 2020
Forxiga recommended for approval in the EU by CHMP for heart failure
19 October 2020 - If approved, Forxiga would become the first SGLT2 inhibitor indicated for heart failure with reduced ejection fraction in patients with and without type 2 diabetes mellitus.
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for an indication extension of its marketing authorisation in the European Union for the treatment of symptomatic chronic heart failure with reduced ejection fraction in adults with and without type 2 diabetes mellitus.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the landmark DAPA-HF Phase 3 trial, published in The New England Journal of Medicine.
