Novo Nordisk’s oral semaglutide, marketed as Rybelsus for type 2 diabetes, has not gained much presence in the GLP-1 receptor agonists (GLP-1RAs) market despite its approval in 2019, as its injectable alternatives prove to have higher efficacy and results both in diabetes and obesity patients. However, the market for oral GLP-1RAs is expanding, and Rybelsus’ latest results showed its benefits in reducing the risk in cardiovascular events in a specific patient population. The results could position Rybelsus at an advantage over competitors, which are expected to enter the market in the next few years, according to GlobalData, a leading data and analytics company.

Recently, Novo Nordisk announced the results of the Phase III SOUL trial, assessing Rybelsus benefits on cardiovascular risk factors. The results showed a 14% overall risk reduction in major adverse cardiac events (MACE) in type 2 diabetes patients with cardiovascular disease with or without chronic kidney disease.

Costanza Alciati, Pharma Analyst at GlobalData, comments: “These results are not a surprise, as injectable semaglutide candidates Ozempic and Wegovy also lower cardiovascular disease risk.”

Indeed, in the SUSTAIN 6 trial, a 26% MACE risk reduction was observed after Ozempic’s treatment, while in the SELECT trial, Wegovy caused a 20% MACE risk reduction.

Alciati continues: “The oral candidate has shown to have a weaker action in multiple instances; in fact, the weight loss effects of Rybelsus are also not comparable to Ozempic’s or Wegovy’s. However, these positive results will probably favor Rybelsus against other oral GLP-1RAs that will enter the space soon. Usually, the cardiovascular outcomes trials are rolled out after the drug enters the market; thus, newly approved drugs rarely have this data.”

Alciati concludes: “An oral drug with cardiovascular benefits may also help drive reimbursement decisions in the near future.”