Merck & Co., Inc. — Steglatro EMA EPAR public assessment report (EMEA/H/C/004315, 2018)
Merck & Co., Inc. · 2018 · EMA EPAR public assessment report · company profile →
Report summary
Merck Sharp & Dohme Limited's marketing authorization application for Steglatro (ertugliflozin) as a monotherapy or add-on for type 2 diabetes mellitus was submitted to the EMA in February 2017. Ertugliflozin, an SGLT2 inhibitor, demonstrated high potency and selectivity in non-clinical studies. Clinical trials consistently showed significant reductions in HbA1c, fasting plasma glucose, body weight, and blood pressure across various patient populations, including those with renal impairment. While generally well-tolerated, safety concerns include increased risks of volume depletion, genital infections, and a slight increase in LDL-C. The overall benefit-risk profile is consistent with other SGLT2 inhibitors, with ongoing monitoring for potential risks like ketoacidosis and bone fracture.
Key findings — cited to the page
| NOEC (Daphnia sp. Reproduction Test, D. magna) | 2140 µg/L | · p.31 |
| Worldwide diabetes prevalence (adults 20-79 years) | 8.8 % | Global · p.8 |
| Proportion of diabetic patients with T2DM | 90 % | Global · p.8 |
| CHMP positive opinion date for marketing authorization | 25 January 2018 | Steglatro · Europe · p.7 |
| Worldwide diabetes prevalence projection (adults 20-79 years) | 10.4 % | Global · p.8 |
| Increase in number of people with diabetes relative to 2015 | 55 % | Global · p.8 |
| FPG change from baseline | -7.70 mg/dL | P002/1013 · p.65 |
| US adults affected by diabetes | 29.1 million | United States · p.8 |
| US adult diabetes prevalence | 9.3 % | United States · p.8 |
| US diabetes prevalence in adults over 65 years | 26 % | United States · p.8 |
| Estimated number of people with diabetes in Europe | 59.8 million | Europe · p.8 |
| EMA/CHMP eligibility agreement date | 22 October 2015 | Steglatro · Europe · p.6 |
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 →