Verquvo Approved for Heart Failure with Reduced Ejection Fraction
The approval was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial.
Diagnosis & Disease Information
Empagliflozin Under Review for Heart Failure with Reduced Ejection Fraction
The sNDA is supported by data from the phase 3 EMPEROR-Reduced trial which compared the efficacy and safety of empagliflozin to placebo, in addition to recommended therapy, in 3730 patients with chronic heart failure with reduced ejection fraction.
FDA Panel Votes on Entresto for HF With Preserved Ejection Fraction
The recommendation was based on data from the double-blind, parallel-group, active-controlled phase 3 PARAGON-HF trial.
Decision on Furoscix Delayed Due to Inspection Requirements
Furoscix is a pH-neutral formulation of furosemide designed for SC administration via a wearable, preprogrammed on-body drug delivery system.
A Review of Treatments for HFrEF and Expert Q&A
Despite substantial advances in therapeutic options for HFrEF, significant gaps remain in the use of guideline-directed medical therapy in these patients.
Mixed Results for Omecamtiv Mecarbil in Heart Failure Study
Findings showed the study met the primary end point of reduction in cardiovascular death or heart failure events.
Empagliflozin Fast Tracked for Improving Outcomes Following Myocardial Infarction
The effect of empagliflozin on all-cause mortality and hospitalization for heart failure will be evaluated in the in phase 3 EMPACT-MI study.
Dapagliflozin Reduces Hyperkalemia Risk in Heart Failure Treated With MRAs
Secondary results from the DAPA-HF trial suggest the sodium-glucose cotransporter 2 inhibitor may enable use of mineralocorticoid receptor antagonists in some patients with heart failure.
In-Hospital Heart Failure Deaths Down With Routine Vaccinations
Patients with heart failure receiving flu, pneumonia vaccinations have lower in-hospital mortality
Empagliflozin Heart Failure Study Meets Primary End Point
The double-blind EMPEROR-Reduced trial enrolled 3730 adults with HFrEF, with and without diabetes.
