FDA Accepts Filing Application for Oral Semaglutide 25 mg, Which If Approved, Would Be The First Oral GLP-1 Treatment for Obesity

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PLAINSBORO, N.J., May 2, 2025 /PRNewswire/ -- Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) submission for an investigational once-daily, 25 mg oral formulation of Wegovy® (semaglutide) for chronic weight management in adults living with obesity or overweight with one or more comorbid conditions and to reduce the risk of major adverse cardiovascular events (MACE) in adults with overweight or obesity and established cardiovascular disease.2 If approved, Wegovy® would become the first oral formulation of a GLP-1 indicated for chronic weight management.

"We are entering a new era of obesity care where patients want individualized treatment plans that address their needs and provide choices, including oral formulations," said Anna Windle, PhD, Senior Vice President, Clinical Development, Medical & Regulatory Affairs at Novo Nordisk Inc. "Novo Nordisk's strong legacy in obesity care and decades of scientific research and innovation have brought us to this moment. We are pleased that the FDA has accepted our submission and look forward to working with regulatory authorities on what would be the first oral GLP-1 treatment for obesity."

The FDA application is based on results from OASIS 4, a 64-week phase 3 randomized, controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI >/= 30 kg/m2) or overweight (BMI >/= 27 kg/m2) with one or more comorbidities.1,3 Patients with diabetes were excluded.1,3

OASIS 4 included a 64-week treatment period including a 12-week dose escalation, and a 7-week off-treatment follow-up period.1,3 In total, 307 participants were randomized 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, as an adjunct to lifestyle intervention for 64 weeks.1,3

The FDA action date to decide on the Wegovy® oral formulation NDA will be in Q4 2025.2

About Wegovy®Wegovy® (semaglutide) injection 2.4 mg is currently approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.4

About obesityObesity is a serious chronic, progressive, and misunderstood disease that requires long-term management.5-7 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.5,7 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.8,9

The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.10,11 In the U.S., about 40% of adults live with obesity.12

About Novo Nordisk Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

References

  • Garvey W, Duque do Vale R, Karlsson T, et al. Efficacy and Safety of Oral Semaglutide 25 mg in Adults With Overweight/Obesity: The OASIS 4 RCT. Oral presentation presented at ObesityWeek® 2024; 3-6 November 2024; Henry B. Gonzalez Convention Center, San Antonio, US. Presentation Oral-108.
  • Oral Semaglutide 25 mg FDA NDA filing; Novo Nordisk data on file.
  • ClinicalTrials.Gov. Research Study Looking at How Well Semaglutide Tablets Taken Once Daily Works in People Who Have a Body Weight Above the Healthy Range (OASIS 4). Last accessed: May 2025. Available at: https://clinicaltrials.gov/study/NCT05564117.
  • Wegovy® (semaglutide) injection 2.4 mg Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; 2025.
  • Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69.
  • Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723.
  • Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203.
  • Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
  • Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.
  • World Obesity Federation. World Obesity Atlas 2023. Last accessed: May 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023.
  • Centers for Disease Control and Prevention. Why it matters. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/php/about/?CDC_AAref_Val=https://www.cdc.gov/obesity/about-obesity/why-it-matters.html.
  • Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed May 2025. Available at: https://www.cdc.gov/nchs/products/databriefs/db508.htm.

    • SOURCE NOVO NORDISK INC.

    Posted : 2025-05-05 18:00

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