Cardiovascular

Entresto (sacubitril-valsartan) from Novartis is FDA indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure. Entresto remains the only FDA-approved option for patients with a variety of heart failure symptoms. A recent pilot study shows that the drug may also benefit patients with heart failure…

The Galien Foundation has revealed its latest nominees for the 2021 Prix Galien USA Award highlighting innovations in biotechnology, pharmaceutical agents, medical technology and digital health products. Entrants to the competition must have received FDA approval within the past five years and demonstrate exceptional therapeutic potential. The Galien Foundation does not use financial data to…

Nexletol is similar to Nexlizet in its FDA indication as an adjunct to diet and statin therapy to treat adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who need additional help lowering of LDL cholesterol. In September, Nexletol began a direct-to-consumer campaign advertising the potential of the drug to support LDL cholesterol-lowering as an adjunct…

Nexlizet from Esperion is FDA-indicated for heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. The indication is intended as an adjunct to diet and statin therapy for patients who need additional help reducing LDL cholesterol levels. The drug, which combines two cholesterol-reducing medicines (bempedoic acid and ezetimibe), won FDA approval early last year.  

FDA has acknowledged that myocarditis and pericarditis are rare possible complications for patients receiving mRNA COVID-19 vaccines from Moderna and Pfizer/BioNTech. The agency, however, estimated that the condition occurs in 12.6 out of one million recipients of the vaccine aged 12 to 39.  The conditions appear to be more common in males.  The FDA warning…

The FDA has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate) oral pellets for children with venous thromboembolism between 3 months and under 12 years old. The indication stipulates that children receiving Pradaxa have received prior treatment with an injectable blood thinner given by injection for at least five days. FDA has also approved Pradaxa in capsule…

Israel’s Health Ministry is researching “tens” of cases of myocarditis, or heart inflammation, in people who have received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). More than five million people in the country have received the vaccine. The agency, however, has not yet established a causal relationship between the events and the vaccine. Pfizer has…

Cardiology trials often adopt composite endpoints that combine several events of clinical interest as the primary efficacy outcome. Time-to-first-event approaches follow the recommendations of regulatory agencies. But composite outcomes that only consider the first event are suboptimal for a chronic disease such as heart failure (HF), which is characterized by recurrent HF hospitalizations since repeat…