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FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults

Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved once-daily Wegovy® pill, the first oral GLP-1 medicine for obesity in the US.3 Wegovy® pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off.3 Wegovy® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart

articleNovo Nordisk A/s Class BDecember 22, 202513/company/novo-nordisk-as-class-b/news/fda-approves-novo-nordisks-wegovyr-pill-the-first-and-only-oral-glp-1-for-weight-loss-in-adults
FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults

About this update from Novo Nordisk A/s Class B

[{"type":"list","items":[{"val":[{"type":"text","content":"Average weight loss of ~17% if all patients stayed on treatment* with Wegovy® (semaglutide) tablets 25 mg (~14% regardless of if patients stayed on treatment**) in the OASIS 4 trial1","length":183,"tagName":"p"}]},{"val":[{"type":"text","content":"1.5 mg starting dose available in early January for $149 per month with savings offers; Wegovy® pill is being produced in the US and robust supply is on-hand ","length":157,"tagName":"p"}]},{"val":[{"type":"text","content":"Wegovy® brand is the only GLP-1 indicated for weight loss proven to help prevent life-threatening CV events for adults with established CVD and either overweight or obesity along with diet and exercise; Wegovy® has been prescribed for approximately 3.2 million people in the US2-4","length":280,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":620,"olType":false},{"type":"text","content":"PLAINSBORO, N.J., Dec. 22, 2025 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved once-daily Wegovy® pill, the first oral GLP-1 medicine for obesity in the US.3 Wegovy® pill is used with a reduced calorie diet and increased physical activity for adults with obesity, or with overweight who also have weight-related medical problems, to help them lose weight and keep it off.3 Wegovy® pill is also indicated to reduce the risk of major adverse cardiovascular events (MACE) such as death, heart attack, or stroke in adults with overweight or obesity and established cardiovascular disease.3 ","length":653,"tagName":"p"},{"type":"text","content":""The launch of Wegovy® in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy® pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in phase 3 trials. We are confident that the expansion of Wegovy® to a pill will help patients who may have not sought or accepted treatment before," said Dave Moore, executive vice president, US Operations at Novo Nordisk. "Wegovy® pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities."","length...

More updates from Novo Nordisk A/s Class B

Novo Nordiskweight losshealthcare providerweight managementreduced calorie dietbody weightsemaglutide