Novo Nordisk A S — Rybelsus EMA EPAR public assessment report (EMEA/H/C/004953, 2020)
Novo Nordisk A S · 2020 · EMA EPAR public assessment report · company profile →
Report summary
The EMA EPAR for Rybelsus (oral semaglutide) details its marketing authorization application for type 2 diabetes treatment. The report covers the drug's quality, non-clinical pharmacology, pharmacokinetics, and toxicology, emphasizing the role of the absorption enhancer SNAC. Clinical trials (PIONEER program) demonstrated dose-dependent reductions in HbA1c and body weight, with superiority over placebo and some active comparators. While showing cardiovascular safety, the trials indicated common, dose-dependent gastrointestinal adverse events, leading to higher discontinuation rates. Long-term safety concerns, particularly regarding neoplasms and diabetic retinopathy, require further monitoring.
Key findings — cited to the page
| Semaglutide potency (cAMP production) | 0.15 nM | · p.22 |
| Semaglutide potency vs GLP-1 (cAMP production) | 8-fold less potent | · p.22 |
| Theoretical relative monoisotopic molecular mass of semaglutide | 4111.115 | · p.12 |
| Oral semaglutide bioavailability | around 1% | Rybelsus · p.11 |
| Marketing authorization procedure | centralised procedure | Rybelsus · Europe · p.6 |
| Active substance status | known active substance | Rybelsus · p.7 |
| Application submission date | 26 April 2019 | Rybelsus · Europe · p.6 |
| Indication | treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise | Rybelsus · p.6 |
| Legal basis for application | Article 8.3 of Directive 2001/83/EC - complete and independent application | Rybelsus · p.6 |
| Semaglutide sequence homology to human GLP-1 | 94% | · p.11 |
| Paediatric Investigation Plan (PIP) status | not yet completed | Rybelsus · p.6 |
| CHMP positive opinion date | 30 January 2020 | Rybelsus · p.9 |
Source: Novo Nordisk A S ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Metabolic library →