Oral Semaglutide Receives Another FDA Approval

On October 18, Novo Nordisk announced that the US Food and Drug Administration (FDA) has approved the oral administration of smeglutide to reduce the risk of major adverse cardiovascular events (MACE) in high-risk adult patients with type 2 diabetes, regardless of whether they have previous cardiovascular events. According to the press release, this approval makes Smeaglutide the first oral GLP-1 drug that can reduce the MACE risk of high-risk adult patients with type 2 diabetes.
This approval is mainly based on the results of a clinical trial SOUL (NCT03914326). SOUL is a multicenter, international, randomized, double-blind, parallel group, placebo-controlled, phase 3b cardiovascular outcome trial with a total of 9650 participants. The purpose of this trial is to evaluate the effect of the combination of oral smeglutide and placebo on the cardiovascular outcomes of patients with type 2 diabetes at high risk of MACE (cardiovascular death, non fatal myocardial infarction or non fatal stroke) on the basis of standard treatment. The SOUL trial was initiated in 2019 with an average follow-up period of 4 years. The primary outcome is the time at which the first major cardiovascular adverse event (MACE; a composite endpoint consisting of cardiovascular death, heart attack, and stroke) occurs. Compared with placebo, the relative risk of MACE was reduced by 14% at 4 years after oral administration of semaglutide (absolute risk was reduced by 2% at 3 years), which is statistically significant.

To sum up, the approval of this indication of oral smeglutide not only provides a convenient and effective key risk management and control tool for patients with type 2 diabetes and high cardiovascular risk, but also marks the expansion of its value in the field of cardiovascular protection into the field of oral administration, achieving a new milestone. This is not only a major victory for Novo Nordisk, but also indicates the further deepening of the treatment concept of diabetes - from simple sugar control to a new era of comprehensive management oriented by cardiovascular outcomes. In the future, as evidence of multiple benefits of GLP-1 drugs continues to accumulate, it will profoundly affect the clinical treatment landscape of hundreds of millions of patients worldwide.

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