Zepbound(Autoinjector)
Metabolic· 1766 cited findings· 2 source documents
Company: Eli Lilly and Company →
What the regulatory reviews say
Zepbound (Autoinjector) is recommended for approval to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity. The applicant proposed indication specifies adults with an initial body mass index (BMI) of 30 kg/m2 or greater. Zepbound received approval for chronic weight management on November 8, 2023, and for T2DM on May 13, 2022.
In efficacy studies, Zepbound demonstrated a difference from placebo in AHI (LS Mean) of -23.8. Patients experienced a percent change from baseline in AHI of -47.7% and -56.2%. Notable safety findings include nausea in 25% of patients receiving Zepbound 5 mg, and hypotension in 2% of patients receiving Zepbound 15 mg. Cholelithiasis was observed in 1.1% of Zepbound patients compared to 1% in placebo, and cholecystitis in 0.7% of Zepbound patients compared to 0.2% in placebo. The drug should be stored in a refrigerator at 36°F to 46°F.
Key figures — cited to the source page
| Difference from Placebo in AHI (LS Mean) | -23.8 | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.140 |
| Percent change from baseline in AHI | -56.2 | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.142 |
| Nausea (ZEPBOUND 5 mg) | 25 | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.16 |
| Hypotension (ZEPBOUND 15 mg) | 2 | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.16 |
| Cholelithiasis (ZEPBOUND) | 1.1 | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.14 |
| Recommended Indication | treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.57 |
| Approval date for chronic weight management indication | November 8, 2023 | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.76 |
| Storage temperature range (refrigerator) | 36°F to 46°F | ELI LILLY AND CO — Zepbound (Autoinjector) FDA Review (NDA/B, p.43 |
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.