NVO's Rybelsus Gets FDA Nod to Reduce Heart Risk in Diabetes Patients

Core Insights - Novo Nordisk received FDA approval for Rybelsus to include cardiovascular risk reduction in adults with type II diabetes [1][6] - Rybelsus is the first oral GLP-1 therapy approved for lowering the risk of major adverse cardiovascular events in high-risk T2D patients [2][6] - The approval is based on positive results from the phase IIIb SOUL study, which showed a 14% relative risk reduction in major cardiovascular events compared to placebo [6][8] Company Developments - Rybelsus was initially approved in 2019 for improving blood sugar control in adults with T2D [3] - The label expansion in the EU also reflects MACE risk reduction for adult T2D patients [3] - The SOUL study indicated that 12% of patients on Rybelsus experienced a CV event compared to 13.8% in the placebo group, resulting in a 2% absolute risk reduction at three years [8] Clinical Data - The SOUL study demonstrated a statistically significant 14% relative risk reduction in major cardiovascular events for Rybelsus [6][8] - Safety profile in the SOUL study was consistent with previous studies, with serious adverse events slightly lower in the Rybelsus group [9] - Gastrointestinal side effects and discontinuation rates due to adverse events were higher in the Rybelsus group compared to placebo [9] Future Prospects - Novo Nordisk is seeking approval for a 25 mg oral formulation of semaglutide (Wegovy pill) for obesity and cardiovascular disease [11] - The company is also pursuing label expansion for Ozempic in treating peripheral artery disease in the U.S. and EU [11] - By broadening indications and introducing new formulations, Novo Nordisk aims to reinforce semaglutide's role in diabetes, obesity, and cardiometabolic diseases [12]