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.
The approval was based on data from the double-blind, placebo-controlled phase 3 VICTORIA trial.
The designation is based on positive topline data from a phase 2 study of 120 adults following open-heart surgery.
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.
A total of 131 cases of COVID-19 were reported in the interim analysis, with no hospitalizations or severe cases noted in participants who received the vaccine.
The approval was based on data from the phase 3 THALES trial (N=11,016) that compared treatment with ticagrelor plus aspirin to aspirin alone in preventing new stroke events.
The application is supported by data from the double-blind, placebo-controlled phase 3 VOYAGER PAD trial.
Avacopan is an orally-administered, small molecule designed to selectively block the complement 5a receptor on destructive inflammatory cells such as blood neutrophils.
The post-hoc analysis included 2 placebo-controlled phase 3 studies (ORION-10 and -11) that evaluated the efficacy and safety of inclisiran sodium in more than 2300 adult patients.
The phase 4 EVAPORATE study assessed the effects of icosapent ethyl on the progression of coronary atherosclerosis in 80 adult patients with elevated triglycerides.
The multicenter, double-blind, placebo-controlled HAUSER-RCT study assessed the efficacy and safety of evolocumab in 157 patients aged 10 to 17 years with HeFH.