SGLT2 inhibitor for patients with HFrEF receives recommendation by CHMP for EU approval
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion on empagliflozin for adults with symptomatic chronic HFrEF with or without T2DM to reduce risk of CV death or hospitalization due to HF. Marketing authorization of empagliflozin in the European Union is thereby recommended by CHMP.
The CHMP’s positive opinion is based on results from the EMPEROR-Reduced trial, which enrolled 3,730 patients with chronic HFrEF. The study was a phase 3, randomized, double-blind trial that investigated once-daily, oral empagliflozin compared to placebo in addition to standard care in patients with HFrEF.
EMPEROR-Reduced demonstrated a significant risk reduction of 25% for CV death or HF hospitalization in the empagliflozin group and results were consistent in subgroups with or without T2DM. The key secondary endpoint revealed a 30% risk reduction for first and recurrent hospitalization due to HF by empagliflozin. Also, decline in kidney function was significantly slowed.
“HF affects 60 million people worldwide and is the leading cause of hospitalizations in Europe. HF is not only impacting the quality of life considerably for those living with this condition, but it also puts a significant pressure on health care systems,” said Faiez Zannad, MD., PhD., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France. “If the marketing authorization is granted by the EU, empagliflozin will provide an important additional treatment option for the people in Europe living with symptomatic chronic HFrEF.”