Wegovy's indications section is rewritten without BMI numbers

Wegovy's "Indications and Usage" section was revised in August 2025, and the eligible population is now described in words rather than by body mass index cutoffs. The current label says the drug is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 12 years and older with obesity, and in adults with overweight in the presence of at least one weight-related comorbid condition ^[1]. The label's "Recent Major Changes" list shows Indications and Usage was revised twice, in 08/2025 and again in 12/2025 ^[1].

What the label says now

The prescribing information posted on DailyMed, last updated June 18, 2026, lists three indications for Wegovy (semaglutide) injection, all in combination with a reduced calorie diet and increased physical activity ^[1]. The first is reducing the risk of major adverse cardiovascular events — cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke — in adults with established cardiovascular disease and either obesity or overweight ^[1]. The second is the weight indication described above ^[1]. The third, added under accelerated approval, is treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis, consistent with stages F2 to F3, in adults; continued approval may depend on a confirmatory trial ^[1].

Wegovy tablets carry the cardiovascular indication and a weight indication for "adults with obesity, or in adults with overweight in the presence of at least one weight-related comorbid condition" ^[1]. None of those bullets attach a BMI number to the words obesity or overweight ^[1].

The label also carries a Limitations of Use statement: taking Wegovy tablets or Wegovy injection at the same time as other semaglutide-containing products, or any other GLP-1 receptor agonist, is not recommended ^[1].

The document does not include the earlier wording that the August 2025 revision replaced, and it does not explain the FDA's reasoning for the change ^[1]. What prompted the rewrite, and whether other obesity drug labels will be worded the same way, is not addressed in this source.

Why it matters for patients

For most people, the BMI thresholds that show up in clinic conversations and insurance paperwork have long been traced back to the label itself. With the indications text now describing obesity and overweight without numbers, those cutoffs effectively come from elsewhere — the criteria used to enroll patients in the clinical trials, and professional guidelines that insurers and clinicians rely on. The label no longer supplies the number on its own.

This is a wording change to an FDA-approved indication, not a change in dosing or safety information. The label still describes once-weekly injection starting at 0.25 mg with escalation every 4 weeks, a usual maintenance dosage of 2.4 mg once weekly, and a once-daily tablet starting at 1.5 mg with a 25 mg maintenance dosage for cardiovascular risk reduction and weight reduction in adults ^[1].

Whether health plans adjust their own prior authorization rules in response is not something the label controls, and this source does not say. Coverage criteria are set by payers and can be stricter than the label.

What happens next

The label's own change log gives the dated milestones: Indications and Usage revised 08/2025 and 12/2025; Dosage and Administration revised 08/2025, 12/2025 and 03/2026; a new Warnings and Precautions subsection on acute kidney injury due to volume depletion in 08/2025; severe gastrointestinal adverse reactions in 10/2025; removal of the "Suicidal Behavior and Ideation" subsection in 02/2026; and a "Never Share WEGOVY FlexTouch Between Patients" subsection in 06/2026 ^[1].

Other parts of the label continue to list the boxed warning about thyroid C-cell tumors seen in rodents, with the human relevance undetermined, and contraindications in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2 ^[1]. Warnings include acute pancreatitis, acute gallbladder disease, hypoglycemia when used with insulin or an insulin secretagogue, and hypersensitivity reactions including anaphylaxis and angioedema reported after marketing ^[1].

Any further revisions to the indications text are not yet known. Labels are updated on the FDA's schedule, and the version on DailyMed is the one to check for current wording.