FYI. Ask your competent? doctor how they are supporting getting this approved in the US. DOING NOTHING; FIRE THEM!
EMA Approves Semaglutide as First GLP-1 RA for Cardiovascular, Stroke-Related Benefits
Novo Nordisk's semaglutide gains EU approval as the first oral GLP-1 RA to reduce cardiovascular risks in type 2 diabetes patients.According to a new announcement, the European Medicines Agency’s Committee for Medicinal Products for Human Use has approved an update to semaglutide’s (Rybelsus; Novo Nordisk) label, allowing the glucagon-like peptide 1 receptor agonist (GLP-1 RA) to be used to reduce cardiovascular death, heart attack, and stroke. With the decision, it becomes the first GLP-1 RA approved in the European Union for type 2 diabetes with a proven cardiovascular benefit. Semaglutide, marketed as Ozempic in the United States and Rybelsus in Europe, became the first and only oral GLP-1 RA approved for the treatment of type 2 diabetes in 2019. This latest indication is based on data from the phase 3 SOUL trial (NCT03914326), in which treatment with the GLP-1 RA reduced cardiovascular death, heart attack, and stroke by 14% vs. placebo when added to the standard of care in adults with type 2 diabetes at high cardiovascular risk. "Heart problems are the leading cause of disability and death for people living with type 2 diabetes. Therefore, treatments that also address heart problems are key to improving not only health outcomes, but also quality of life—and this approval will help do just that," Emil Kongshøj Larsen, executive vice president, international operations at Novo Nordisk, said in a statement.1 "This milestone makes semaglutide the only oral GLP-1 RA with proven blood glucose and body weight reduction, as well as cardiovascular benefits."
No comments:
Post a Comment