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Sotagliflozin (Inpefa) is a dual SGLT1/SGLT2 inhibitor approved by the US Food and Drug Administration (FDA) in May 2023, to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes, chronic kidney disease, and other cardiovascular risk factors ...
Novo Nordisk expects to file for regulatory approval of a label expansion for Rybelsus in the US and EU around late 2024 or early 2025. The detailed results from SOUL will be presented at a ...
The main efficacy measurement was the time to death from cardiovascular causes or need to be hospitalized for heart failure. [33] Of the individuals who received empagliflozin for an average of about two years, 14% died from cardiovascular causes or were hospitalized for heart failure, compared to 17% of the participants who received the ...
GLP-1 agonists were developed initially for type 2 diabetes. [5] The 2022 American Diabetes Association (ADA) standards of medical care in diabetes include GLP-1 agonist or SGLT2 inhibitor as a first line pharmacological therapy for type 2 diabetes in patients who have or are at high risk for atherosclerotic cardiovascular disease or heart failure.
Novo had at the time said it had filed for an expansion of Wegovy's approved use in the U.S. and Europe to include heart-disease treatment. The FDA's approval of the new cardiovascular indications ...
FRANKFURT (Reuters) -The European Union's drug regulator will this week consider wider use of Novo Nordisk's weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.
Under the US approval, ertugliflozin is contraindicated for patients with severe kidney failure, end-stage renal disease, and dialysis. [3] The European Union approval does not list any contraindications apart from hypersensitivity to the drug, which is standard for all drug approvals.
Merck (MRK)/Bayer's (BAYRY) vericiguat gets approval for symptomatic chronic heart failure in patients with reduced ejection fraction in Europe.
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