Wegovy
Metabolic· 3136 cited findings· 3 source documents
Company: NOVO →
What the regulatory reviews say
Wegovy (semaglutide) is indicated for chronic weight management in adults, with an approval date of June 4, 2021, and for adolescents, approved on December 23, 2023. A recent approval was granted on March 8, 2024. The initial dosage for Wegovy tablets is 1.5 mg once daily, with a maintenance dosage of 25 mg orally once daily, or an alternative maintenance dosage of 1.7 mg once weekly.
In efficacy trials, Wegovy demonstrated a significant reduction in body weight. Participants achieved a body weight reduction of ≥5% in 88.47% of cases. The estimated treatment difference in body weight change versus placebo was -14.81 % points. The drug also showed a hazard ratio of 0.88 for Time to First EAC-Confirmed MACE. The overall AE rate for semaglutide 7.2 mg was 85.1%, compared to 76% for placebo. Alopecia was reported in 5.8% of participants on semaglutide 7.2 mg, increasing to 9.0% in those with ≥20% weight loss.
Key figures — cited to the source page
| Proportion of participants achieving body weight reduction ≥5% | 88.47 | Novo Nordisk A S — Wegovy EMA EPAR variation assessment repo, p.5 |
| Estimated treatment difference (ETD) in body weight change vs placebo | -14.81 | Novo Nordisk A S — Wegovy EMA EPAR variation assessment repo, p.5 |
| Time to First EAC-Confirmed MACE | 0.88 | NOVO — Wegovy FDA Review (NDA/BLA 215256, 2024), p.119 |
| Overall AE rate (semaglutide 7.2 mg) | 85.1 | Novo Nordisk A S — Wegovy EMA EPAR variation assessment repo, p.6 |
| Overall AE rate (placebo) | 76 | Novo Nordisk A S — Wegovy EMA EPAR variation assessment repo, p.6 |
| Alopecia (semaglutide 7.2 mg) | 5.8 | Novo Nordisk A S — Wegovy EMA EPAR variation assessment repo, p.6 |
| Approval Date | March 8, 2024 | NOVO — Wegovy FDA Review (NDA/BLA 215256, 2024), p.1 |
| Maintenance dosage of WEGOVY tablets | 25 mg | NOVO — Wegovy FDA Review (NDA/BLA 215256, 2026), p.10 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.