What's Happening?
The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk's Rybelsus, an oral semaglutide, for reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes
who are at high risk. This approval is based on the results of the SOUL trial, which demonstrated a 14% reduction in the risk of MACE compared to placebo. Rybelsus is now the only oral GLP-1 medication approved for this indication, marking a significant milestone in the treatment of type 2 diabetes and cardiovascular risk management.
Why It's Important?
This approval is significant as it provides a new oral treatment option for reducing cardiovascular risk in patients with type 2 diabetes, a group that is at increased risk for heart attacks and strokes. The availability of an oral GLP-1 receptor agonist that can effectively reduce cardiovascular events expands the therapeutic options for managing diabetes and its complications. This could lead to improved patient adherence and outcomes, as oral medications are often preferred over injectable treatments.
What's Next?
Novo Nordisk plans to continue its efforts to expand the use of semaglutide in other therapeutic areas, including obesity. The company has submitted a supplemental application for a once-daily oral formulation of semaglutide for obesity treatment, with a decision expected later this year. The ongoing development and approval of semaglutide formulations could further solidify Novo Nordisk's position as a leader in the cardiometabolic field.
