Merck & Co., Inc. — Steglujan EMA EPAR public assessment report (EMEA/H/C/004313, 2018)
Merck & Co., Inc. · 2018 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of Steglujan (ertugliflozin/sitagliptin) for type 2 diabetes led to a positive opinion for marketing authorization. The fixed-dose combination, indicated as an adjunct to diet and exercise when other treatments are insufficient, demonstrated significant reductions in HbA1c, fasting plasma glucose, and body weight in Phase 3 trials. Non-clinical studies confirmed ertugliflozin's SGLT2 selectivity and safety profile. Key safety concerns included genital mycotic infections, hypoglycemia, and volume depletion, particularly in vulnerable populations. The report details quality aspects, pharmacokinetics, toxicology, and environmental risk, concluding with a favorable benefit-risk balance.
Key findings — cited to the page
| Shelf-life | 2 years | Steglujan · p.19 |
| Ertugliflozin IC50 for rat SGLT2 | 1.15 nM | · p.20 |
| FPG change from baseline | -36.91 mg/dL | P005/1019 · p.64 |
| Odds Ratio for A1C < 7.0% vs Placebo | 4.43 | P006/1015 · p.73 |
| Ertugliflozin IC50 for human SGLT2 | 0.877 nM | · p.20 |
| Ertugliflozin IC50 for human SGLT1 | 1960 nM | · p.20 |
| CHMP positive opinion date | 25 January 2018 | Steglujan · EU · p.8 |
| FPG change from baseline | -35.73 mg/dL | P005/1019 · p.64 |
| HbA1c change from baseline | -0.78 % | P006/1015 · p.62 |
| Ertugliflozin/sitagliptin fixed-dose combination strengths | 5 mg/100 mg, 15 mg/100 mg | Steglujan · p.11 |
| Marketing authorisation application submission date | 1 February 2017 | Steglujan · EU · p.7 |
| Ertugliflozin IC50 for dog SGLT2 | 0.118 nM | · p.20 |
Source: Merck & Co., Inc. ↗ · 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 →