Novo Nordisk’s oral semaglutide confirmed for CV risk reduction

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Announcement 

Novo Nordisk received approval from the US Food and Drug Administration (FDA) for Rybelsus. The Rybelsus® is the first ever GLP-1 medication for alleviating the risk of crucial adverse cardiovascular events (MACE) like heart attack, stroke or cardiovascular (CV) death in the adult population having type 2 diabetes, regardless of whether they’ve had previous CV symptoms or not. The results of the SOUL trial bolster the semaglutide molecule’s clinical profile, with various experts' confirmation of the study throughout numerous therapeutic areas.

The newest medication for Rybelsus makes the approval worthwhile. It holds the potential to deliver for primary prevention that mitigates the risk of crucial adverse cardiovascular events by managing or curing risk factors in the adult population having the highest risk for these events, and secondary prevention by mitigating the risk of other circumstances in individuals with extreme CV events. Apart from this approval, Novo Nordisk has submitted a supplemental application in the US for the oral formulation of semaglutide (once-daily) in its commercial name Wegovy for the obesity treatment.

SOUL Trial Potential

The first and important objective of the phase 3b SOUL trial was to examine the impact of the oral semaglutide 14 mg, including the standard of care for diminishing the risk factor of MACE in adults with type 2 diabetes having advanced risk for crucial cardiovascular events. The primary conclusion of the study was the timeframe to the first presence of MACE involving a 3-point composite of CV death, nonfatal stroke or nonfatal myocardial infarction.

The MACE events were shown in 579/4825 participants were having 12.0% of the semaglutide group, and the other 668/4825 participants with 13.8% of the placebo group. The oral semaglutide 14 mg elaborated the measurable prominent 14% relativity in mitigated risk of MACE at 4 years by 2% in comparison with placebo. These results integrate into the extensive body of real-world evidence and randomised clinical trials contributing to semaglutide.

Healthcare Leaders’ Statement

The executive vice president, US operations of Novo Nordisk Inc, Dave Moore, said, “Being the only FDA-approved GLP-1 therapy in a pill form has now received recognition for its evident cardiovascular benefits. This proves to be a new milestone for its future oral innovations. The semaglutide molecule has continuously elaborated the comprehensive outcomes throughout the various large-scale trials. This further supports the previously developed cardiovascular profile that is served for patients.”