HomeMedicationIf the FDA is approved, the FDA accepts the application for 25 mg of oral semagluide, which will be the first oral GLP-1 treatment for obesity.

If the FDA is approved, the FDA accepts the application for 25 mg of oral semagluide, which will be the first oral GLP-1 treatment for obesity.

Medication

May 5, 2025

byhealthnova

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NOVO NORDISK hopes to expand Wegovy^® It becomes the first and attaches the label GLP-1 Pill
The FDA submission is based on the results of the 3 -phase Oasis 4 exam, which evaluated 25 mg of oral cavity and overweight adults who are obese or overweight.¹
NOVO NORDISK continues to build more than 100 years of legacy of science and innovation.

Plain Boro, New Jersey,,, May 2, 2025 / Prnewswire/-Today, Novo Nordisk has announced that the US Food and Drug Administration (FDA) has accepted a new drug application (NDA) for once a day.^® (Semaglutide) Reduces the risk of major side effects of the adults with one or more accompanying diseases for chronic weight management of obesity or overweight adults.² WEGOVY for approval^® It will be the first oral formulation of A GLP-1 It is displayed for chronic weight management.

Anna Windle, vice president of clinical development and vice president of medical and regulations at Novo Nordisk Inc., said, “We are planning a new obesity treatment plan that wants patients to solve their own needs and provide individualized treatment plans that provide choices including oral formulations. GLP-1 Obesity treatment. “

FDA applications are based on the results of Oasis 4, a 64 -week 3 -phase control test that assesses the efficacy and safety of 25 mg of oral semi -glute on 307 people with obesity (BMI>/= 30 kg/m.²) Or overweight (bmi>/= 27 kg/m²) One or more accompanying diseases.^1,3 Diabetes were excluded.^1,3

Oasis 4 includes a 12 -week dose escalation and a 64 -week processing period, including the after treatment period after treatment for 7 weeks.^1,3 A total of 307 participants were randomly assigned at a 2: 1 ratio for 25 mg of oral semagluide or placebo for 64 weeks.^1,3

The FDA measure date determines Wegovy^® The oral formulation NDA will be in the fourth quarter of 2025.²

About Wegovy^®

Wegovy^® (SEMAGLUTIDE) Injection 2.4 mg is currently in some adults with adults over 12 years of age and adults and children, children or weight -related medical problems in adults, children, or weight -related problems in the case of adults and physical problems. It helps to take or deliberately look at it.⁴

About obesity

Obesity is a serious chronic, progressive and misunderstood disease that requires organ care.^5-7 One main misunderstanding is that this is a disease that lacks willpower. In fact, when people with obesity have a fundamental biology that can interfere with weight loss and prevent it.^5,7 Obesity is influenced by various factors, including genetics, social decision factors and environments of health.^8,9

The prevalence of overweight and obesity is a public health problem that affects the medical system at a serious cost.^10,11 In the United States, about 40%of adults live in obesity.¹²

Novo Nordisk Information

NOVO NORDISK is a world -class medical company that creates innovative medicines for people with diabetes for more than 100 years and longer and more healthy lives. This heritage has given experience and ability to make people change to defeat other serious chronic diseases such as obesity, rare blood and endocrine disorders. We are to focus on and think in the long term, and to carry out business in a financial, social and environmentally responsible way. NOVO NORDISK USA is headquartered in New Jersey for 40 years, and employs more than 10,000 people nationwide in 12 manufacturing, R & D and corporate areas of eight states and Washington DC. Please visit more detailsNovonordisk-us.com,,,Facebook,,,InstagramandX.

reference

Garvey W, Duque Do Vale R, Karlsson T, etc. Shoes presentation published in ObesityWeek^® 2024; November 3-6, 2024; Henry B. Gonzalez Convention Center, San AntonioWe. Presentation Shoes -108.
Oral Semagluide 25 mg FDA NDA submission; NOVO NORDISK data of the file.
ClinicalTrials.gov. Research is a study of how well it works for the anti -glue tide (Oasis 4), which was taken once every day for people who have a healthy range. Last approach: May 2025. Can be used: https://clinicalTrials.gov/study/nct05564117.
Wegovy^® (Semaglutide) Injection 2.4 mg prescription information. Plain Boro, New Jersey: Novo Nordisk Inc.; 2025.
Recognition of barriers to effective obesity treatment such as Kaplan LM, Golden A, Jinnett K: Results of national behavioral research. obesity. 2018; 26 (1): 61-69.
Bray Ga, Kim KK, Wilding JPH; World Obesity Union. Obesity: Chronic recurrent progressive disease process. Status of the World Obesity Union. rotation. 2017; 18 (7): 715-723.
Garvey WT, Mechanick Ji, Brett EM, etc. Endocrine practices. 2016; 22 (Suppl 3): 1-203.
Disease Control and Prevention Center. Adult obesity facts. Last approach: May 2025. Can be used: https://www.cdc.gov/obesity/adult-obesity-Facts/index.html.
Disease Control and Prevention Center. Risk factors of obesity. Last approach: May 2025. Can be used: https://www.cdc.gov/obesity/risk-Factors/risk-Factors.html.
World Obesity Union. World Obesity Atlas 2023. Last approach: May 2025. Can be used: https://www.wordobesity.org/Resources/Resource-library/world-besity-atlas-2023.
Disease Control and Prevention Center. Why is it important? Last approach: May 2025. Can be used: https://www.cdc.gov/obesity/php/about/?cdc_aaref_val=https://www.cdc.gov/obesity/about-obesity/why-matters.html.
Disease Control and Prevention Center. Obesity and serious obesity prevalence of adults: USAAugust 2021 -August 2023. Last approach May 2025. Can be used: https://www.cdc.gov/nchs/products/databriefs/db508.htm.