Rybelsus, a daily pill approved in 2019 for Type 2 diabetes, contains the same active ingredient as Ozempic and Wegovy.
The study enrolled 9,650 Type 2 diabetes patients who have cardiovascular disease and/or chronic kidney disease. The primary outcome was defined by the first occurrence of MACE, defined as cardiovascular death, non-fatal myocardial infarction or non-fatal stroke. Rybelsus was found to be safe and well-tolerated.
In March, the FDA approved Wegovy to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease who are either obese or overweight.
In the next few months, Novo Nordisk plans to file for an expanded label for Rybelsus in the U.S. and E.U. based on the phase 3 results.
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