NOVO — Rybelsus FDA Review (NDA213051, ORIG 1, 2019)
NOVO · 2019 · FDA Review (openFDA)
Report summary
The FDA review of Novo Nordisk's Rybelsus (oral semaglutide) for Type 2 Diabetes Mellitus recommends approval based on six randomized controlled trials. These trials demonstrated statistically significant reductions in HbA1c and body weight compared to placebo and active controls. While effective for glycemic control, Rybelsus 14 mg showed higher rates of gastrointestinal adverse events. The review also addresses labeling recommendations, including a correction for FPG change. Carcinogenicity studies of the absorption enhancer salcaprozate sodium (SNAC) in rats revealed a positive dose-response for lipoma and liposarcoma in male rats, though no significant tumor incidence was found in mice.
Key findings — cited to the page
| NDA Number | 213051 | Semaglutide · p.2 |
| Indication | Type 2 Diabetes Mellitus (T2DM) | · p.2 |
| Applicant | Novo Nordisk | · p.2 |
| Drug Name | Semaglutide | · p.2 |
| PDUFA Due Date | September 20, 2019 | · p.2 |
| Review Priority | Expedited | · p.2 |
| Number of randomized trials reviewed for effectiveness | 6 | Semaglutide · p.6 |
| Primary efficacy endpoint | Week 26 change from baseline percent concentration of HbA1c (ΔHbA1c) | · p.8 |
| Secondary efficacy endpoint | Week 26 change from baseline body weight (ΔBW) | · p.8 |
| Received Date | March 20, 2019 | · p.2 |
| Hypoglycemia Event Rate (Alert) | 0.092 Events per Treatment-Year | Trial 4224 · p.30 |
| Hypoglycemia Event Rate (Alert) | 0.227 Events per Treatment-Year | Trial 4224 · p.30 |
Source: NOVO ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →