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The U.S. Food and Drug Administration (FDA) has approved a pill from Novo Nordisk, known as oral semaglutide or Rybelsus, for the reduction of cardiovascular risks in adults with type 2 diabetes who are at high risk. The approval, based on a trial that showed a 14% reduction in risk of complications like heart attack, stroke or cardiovascular death, confirms the additional health benefits of GLP-1s, beyond blood sugar regulation and weight loss. By the end of the year, a decision is expected on whether to approve the pill for obesity, potentially making it the first-ever GLP-1 pill approved for this purpose.
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Novo Nordisk’s GLP-1 Pill Gains Approval for Cardiovascular Benefits
The Danish pharmaceutical company Novo Nordisk recently celebrated a significant achievement, as its pill for type 2 diabetes earned approval for decreasing cardiovascular risks. This development reaffirms the broader health advantages of GLP-1s, including both oral and injectable forms, beyond blood sugar regulation and weight loss.
On Friday, the Food and Drug Administration authorized oral semaglutide for the reduction of major cardiovascular events, such as heart attacks, strokes, or cardiovascular deaths, in high-risk individuals with type 2 diabetes. The SOUL trial demonstrated a 14% risk reduction of these events over four years compared to a placebo, following a daily 14-milligram dosage of the pill.
Oral semaglutide, marketed as Rybelsus for diabetes, has been available since 2019 and is the only FDA-approved GLP-1 pill. It is also the active ingredient in Novo Nordisk’s popular obesity injection, Ozempic, and the Wegovy obesity treatment, both approved for heart health in obese individuals with established cardiovascular disease.
Taking note of the broader implications of this development, Dr. John Buse, director of the University of North Carolina School of Medicine Diabetes Care Center and co-chair of the SOUL trial, stated, “Having an oral GLP-1 therapy to help improve glycemic control was an innovation in and of itself… This new indication, based on the SOUL data, marks even further advancement and showcases the versatility of semaglutide while expanding options for millions of people.”
Awaiting FDA Decision on Oral Semaglutide for Obesity
Industry observers are anticipating another FDA decision to be made by the end of the year—whether to approve oral semaglutide for treating obesity. Patients using weight loss drugs eagerly await a more convenient option to address the supply shortages and access difficulties caused by current expensive weekly injections.
If approved, oral semaglutide would be the first-ever GLP-1 pill for obesity treatment. However, a potential competitor from Eli Lilly named Orforglipron is closely following Novo Nordisk’s progress. Eli Lilly’s CEO, Dave Ricks, has expressed hopes of launching the pill globally by next year.
Oral Semaglutide and Orforglipron: A Race for Market Share
Analysts are curious to see which of the two drugs could secure a larger market share. Based on obesity trials, Eli Lilly’s efficacy appears slightly below that of Novo Nordisk’s oral semaglutide. However, Orforglipron, a small-molecule drug, has advantages in being easier to absorb in the body and not requiring dietary restrictions, unlike Novo Nordisk’s peptide medication.
Both Novo Nordisk and Eli Lilly are investigating further applications for their pills. While Novo Nordisk is exploring the use of oral semaglutide in patients with Alzheimer’s disease, Eli Lilly has separate trials for Orforglipron in patients with obstructive sleep apnea and hypertension.
Stay tuned for further coverage as more information becomes available. Tip and story suggestions are welcomed at annika.constantino@versantmedia.com.
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