Germany-based Boehringer Ingelheim and United States-based Eli Lilly and Company have revealed that The US Food and Drug Administration (FDA) has granted fast track designation to Empagliflozin for the decrease of cardiovascular death and hospitalisation for heart failure in people with chronic heart failure, it was reported yesterday.
The Fast Track designation allows the development of new therapies that complete an unmet medical requirement for serious conditions in an effort to accelerate the availability of new treatment options.
The fast track designation is for the ongoing EMPEROR program, which includes the EMPEROR-Reduced and EMPEROR-Preserved studies. These studies will assess the effect of Empagliflozin on cardiovascular death and hospitalisation for heart failure in adults with chronic heart failure with decreased or preserved ejection fraction, respectively.
The empagliflozin chronic heart failure program consists of the EMPEROR-Reduced and EMPEROR-Preserved studies, the EMPERIAL-Reduced and EMPERIAL-Preserved studies and the EMPA-VISION study. These studies are evaluating the efficacy and safety of empagliflozin in more than 9,000 adults with chronic heart failure, including those with and without diabetes.
Seismic Pharmaceuticals enrols first patient in istaroxime global Phase 3 trial in cardiogenic shock
Ionis partner Novartis reports pelacarsen Phase 3 trial misses primary endpoint
Thryv Therapeutics licenses new class of SGK1 inhibitors, expanding into neurodegenerative disease
Lilly to acquire Merida Biosciences in USD2.875bn deal
GE HealthCare expands Vivid cardiovascular ultrasound portfolio with three new systems
Daiichi Sankyo data highlight real-world impact of bempedoic acid on cardiovascular risk
Revier Therapeutics closes EUR6m seed financing and launches operations
Tempus announces receipt of FDA clearance for AI pulmonary hypertension detection product
European Commission grants orphan designation for Lundbeck's asedebart
Hanmi Pharm enters exclusive licensing deal with Genentech for obesity therapy HM17321
PTC to acquire BLA-stage ST-920 Fabry disease programme
Olio Labs reveals study demonstrating AI-driven in vivo platform can predict clinical trial outcomes
Mezzion Pharma Co reports positive results from new in vivo study of udenafil
Incyte's Opzelura approved in European Union for moderate atopic dermatitis