Congestive Heart failure (CHF) is a life-threatening disease in which the heart cannot pump enough blood around the body. It affects approximately 64 million people worldwide (half of which have a reduced ejection fraction) and is a chronic and degenerative disease.
According to the most recent data from the Centers for Disease Control and Prevention (CDC), in 2016 there were around 5.7 million people in the United States living with heart failure and nearly half (48 percent, 121.5 million in 2016) of all adults in the United States have some type of cardiovascular disease.
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Heart failure is also known as congestive heart failure (CHF). CHF is a condition in which the heart is no longer able to pump out enough oxygen-rich blood. Symptoms include cough, fatigue, weakness, faintness, loss of appetite, swollen (enlarged) liver or abdomen, swollen feet and ankles and weight gain.
There are two types of heart failure including systolic heart failure (left ventricle loses its ability to contract normally) and diastolic heart failure (left ventricle loses its ability to relax normally). The predisposing factors include high blood pressure, diabetes, sleep apnea, alcohol use and irregular heartbeats. Treatment includes surgery, vasodilator, beta blockers and diuretics.
Congestive Heart Failure pipeline therapeutics constitutes close to 180 molecules. Out of which approximately 155 molecules are developed by Companies and remaining by the Universities/Institutes.
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Prominent Phase III CHF Drugs
1. Entresto:
On October 1, 2019, Novartis has announced that the U.S. Food and Drug Administration (FDA) has approved Entresto® (sacubitril/valsartan) for the treatment of symptomatic heart failure (HF) with systemic left ventricular systolic dysfunction in pediatric patients aged 1 year and older. Entresto reduces NT-proBNP and is expected to improve cardiovascular outcomes. Entresto (sacubitril/valsartan) is a prescription medicine used to reduce the risk of cardiovascular death and heart failure hospitalization in people with certain types of long-lasting (chronic) heart failure (HFrEF).
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2. Farxiga:
On September 1, 2019, AstraZeneca announced detailed results from the landmark Phase III DAPA-HF trial that showed
Farxiga (dapagliflozin) on top of the standard of care reduced both the incidence of cardiovascular death and the worsening of heart failure (HF). AstraZeneca is committed to advancing science and
clinical trial outcomes with Farxiga in the treatment of people with HF. Farxiga is a first-in-class, oral once-daily SGLT2 inhibitor indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction.
Farxiga is also being studied in patients with heart failure with preserved ejection fraction (HFpEF) in the DELIVER and DETERMINE (HFrEF and HFpEF) trials.
3.ÌýJardiance:
On June 26, 2019, Boehringer Ingelheim and Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure. Jardiance (empagliflozin; Boehringer Ingelheim/Eli Lilly) is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor originally developed by Boehringer Ingelheim for the treatment of type 2 diabetes. As part of the companies' strategic diabetes alliance, Jardiance's late-stage development and commercialization were conducted with Eli Lilly. Jardiance is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.
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The Congestive Heart Failure Pipeline Report provides comprehensive information on the therapeutics under development for Congestive Heart Failure, complete with analysis by stage of development( Phase III, Phase II, Phase I), drug target, mechanism of action (MoA), route of administration (RoA) and molecule type.
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4.ÌýZynquista:
In July 2019, Lexicon Pharmaceuticals, Inc., announced preliminary results from Sanofi for three Phase 3 trials of Zynquistaâ„¢ (sotagliflozin) in adults living with type 2 diabetes.Ìý Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). Lexicon has granted Sanofi an exclusive worldwide (excluding Japan) license to develop, manufacture and commercialize Zynquista. Lexicon remains responsible for all clinical development activities relating to type 1 diabetes and Sanofi is responsible for all clinical development activities of Zynquista for the treatment of type 2 diabetes. SGLT-2 inhibitor, sotagliflozin also tested on patients with CHF and comorbid T2D who experience worsening HF. Sotagliflozin became the third SGLT-2 inhibitor to undergo development in this indication and is being investigated in T2D patients with both HFrEF and HFpEF in the same trial.Ìý
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Note: Information sourced from company press releases***Ìý