Novo Nordisk AS (NVO) on Thursday said the U.S. Food and Drug Administration approved a new indication for Ozempic, or semaglutide, to “reduce the risk of major adverse cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes and known heart disease.”
Novo Nordisk said the FDA’s decision was based on results from the SUSTAIN 6 trial, a two-year study examining “the cardiovascular safety of adding Ozempic or placebo to standard of care in adults with type 2 diabetes and established cardiovascular disease.”
“There is a well-established link between cardiovascular disease and type 2 diabetes. It’s one of our biggest concerns with type 2 diabetes because even when patients reach their blood sugar targets, the risk of a major adverse CV event remains,” said Todd Hobbs, vice president and U.S. chief medical officer of Novo Nordisk. “Today’s milestone establishes Ozempic as an option for patients to help address two critical aspects of managing type 2 diabetes, blood sugar control and cardiovascular risk reduction, in those with known heart disease.”
Ozempic is already indicated for use by certain patients to improve blood sugar and reduce the risk of major cardiovascular events such as heart attack, stroke or death in adults with type 2 diabetes mellitus with known heart disease, the company said.
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