The Food and Drug Administration has approved Wegovy™ (semaglutide injection) as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obesity); or 27 kg/m2 or greater (overweight) in the presence of at least 1 weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).

Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. It works by targeting areas of the brain that regulate appetite and food intake.

The approval was based on three 68-week double-blind, placebo-controlled studies (Studies 1, 2, 3), in which Wegovy or placebo was escalated to 2.4mg subcutaneous weekly during a 16-week period followed by 52 weeks on maintenance dose, as well as one 68-week withdrawal trial (Study 4), in which Wegovy was escalated during a 20-week run-in period, and patients who reached 2.4mg after the run-in period were randomly assigned to either continue treatment or placebo for 48 weeks.

In Studies 1, 2, and 3, the primary efficacy endpoints were mean percent change in body weight and the percentages of patients achieving greater than or equal to 5% weight loss from baseline to week 68. Findings from these studies showed that treatment with Wegovy resulted in statistically significant reductions in body weight, with a greater proportion of patients achieving 5%, 10%, and 15% weight loss, compared with placebo.


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Study 1 (ClinicalTrials.gov Identifier: NCT03548935) included 1961 patients with obesity or with overweight and at least 1 weight-related comorbid condition; mean baseline body weight was 105.3kg and mean BMI was 37.9kg/m2. Wegovy-treated patients (n=1306) lost an average of 12.4% (95% CI, -13.3, -11.6) of their initial body weight compared with those who received placebo (n=655) (P <.0001).

Study 2 (ClinicalTrials.gov Identifier: NCT03552757) enrolled 807 patients with type 2 diabetes and a BMI of at least 27kg/m2; mean baseline body weight was 99.8kg and mean BMI was 35.7kg/m2. In this study, patients who received Wegovy (n=404) lost an average of 6.2% (95% CI, -7.3, -5.2) of their initial body weight compared with placebo (n=403) (P <.0001).

Study 3 (ClinicalTrials.gov Identifier: NCT03611582) included 611 patients with obesity or with overweight and at least 1 weight-related comorbid condition who were undergoing intensive lifestyle therapy; mean baseline body weight was 105.8kg and mean BMI was 38.0kg/m2. Findings showed that Wegovy-treated patients (n=407) lost an average of 10.3% (95% CI, -11.8, -8.7) of their initial body weight compared with placebo (n=204) (P <. 0001).

In Study 4 (ClinicalTrials.gov Identifier: NCT03548987), the primary efficacy measure was mean percent change in body weight from randomization (week 20) to week 68. The mean body weight change was observed to be -7.9% with continued Wegovy treatment vs + 6.9% with placebo (% difference from placebo, -14.8 [95% CI, -16.0, -13.5]; P <.001).

As for safety, the most common adverse reactions reported included nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, abdominal distention, eructation, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease. The prescribing information for Wegovy also includes a Boxed Warning regarding the risk of thyroid C-cell tumors; Wegovy is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in those with multiple endocrine neoplasia syndrome type 2.

Wegovy should not be used in combination with other semaglutide-containing products (eg, Ozempic) or any other GLP-1 receptor agonist. Additionally, the safety and efficacy of coadministration with other products for weight loss have not been established.

Wegovy is supplied as prefilled, single-dose pens that deliver doses of 0.25mg, 0.5mg, 1mg, 1.7mg, or 2.4mg. Treatment is administered subcutaneously once weekly by the patient following training on proper technique.

The product is expected to be available later this month.

References

  1. Novo Nordisk receives FDA approval for Wegovy™ to treat adults with obesity based on unprecedented efficacy for a prescription medicine in clinical trials. [press release]. Plainsboro, NJ: Novo Nordisk Inc; June 4, 2021.
  2. FDA approves new drug treatment for chronic weight management, first since 2014. [press release]. Silver Spring, MD: Food and Drug Administration; June 4, 2021.
  3. Wegovy [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2021.