semaglutide
Metabolic· 1501 cited findings· 2 source documents
Company: Novo Nordisk A S →
What the regulatory reviews say
Semaglutide is a drug developed by Novo Nordisk A/S for the treatment of Type 2 Diabetes Mellitus (T2DM). The New Drug Application (NDA 213051) for semaglutide was received by the FDA on March 20, 2019, with a PDUFA Due Date of September 20, 2019. The regulatory review included 6 randomized trials for effectiveness.
Efficacy findings from the FDA review of Rybelsus (semaglutide) showed reductions in HbA1c from baseline, with values ranging from -0.06% to -1.40%. For instance, one trial reported a change of -0.89% from baseline, another -1.16%, and a third -1.40%. Safety data indicated hypoglycemia event rates of 0.092 and 0.227 events per treatment-year. The percent incidence of 'Alert' hypoglycemia ranged from 18.2% to 24.1%, while 'Clinically Significant' hypoglycemia incidence ranged from 6.4% to 9.4%.
Key figures — cited to the source page
| HbA1c change from baseline (%) | -0.89 | NOVO — Rybelsus FDA Review, p.21 |
| HbA1c change from baseline (%) | -1.40 | NOVO — Rybelsus FDA Review, p.21 |
| HbA1c change from baseline (%) | -0.06 | NOVO — Rybelsus FDA Review, p.21 |
| Hypoglycemia Event Rate (Alert) | 0.092 | NOVO — Rybelsus FDA Review, p.30 |
| Hypoglycemia Event Rate (Alert) | 0.227 | NOVO — Rybelsus FDA Review, p.30 |
| Hypoglycemia Percent Incidence (Alert) | 24.1% | NOVO — Rybelsus FDA Review, p.28 |
| Hypoglycemia Percent Incidence (Clinically Significant) | 9% | NOVO — Rybelsus FDA Review, p.28 |
| NDA Number | 213051 | NOVO — Rybelsus FDA Review, p.2 |
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.