ertugliflozin
Metabolic· 3273 cited findings· 3 source documents
Company: Merck & Co., Inc. →
What the regulatory reviews say
Ertugliflozin is a drug indicated for the treatment of type 2 diabetes mellitus. Regulatory documents report its efficacy in achieving glycemic control, with various proportions of subjects reaching A1C < 7.0%. For instance, one study observed 43.5% of subjects achieving A1C < 7.0%, while another reported 34.4%. Adjusted Odds Ratios for achieving A1C < 7.0% were noted as 0.68 and 0.79 in different analyses. The drug also demonstrated effects on blood pressure, with Sitting Systolic Blood Pressure Change from Baseline ranging from -4.38 mmHg to -5.20 mmHg, and Sitting Diastolic Blood Pressure Change from Baseline ranging from -1.59 mmHg to 0.23 mmHg.
Key safety findings from regulatory reviews include incidences of various adverse events. Bronchitis was reported at 1.8% and 2.3%, while Gastroenteritis incidence ranged from 0.2% to 1.6%. Hepatic steatosis was observed at 0.2% and 1.1%, and Influenza at 3.1%. Back pain incidence was 0.8%. A placebo arm in one study showed a Fall incidence of 45.
The marketing authorization application for ertugliflozin was submitted on 27 January 2017, with a CHMP positive opinion issued on 25 January 2018. The CHMP adoption of conclusions date is noted as 29 January 2026. The procedure number for the regulatory review is EMA/PAM/0000307025.
Key figures — cited to the source page
| Proportion of subjects with A1C<7.0% | 43.5 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.71 |
| Proportion of subjects with A1C<7.0% | 34.4 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.71 |
| Sitting Systolic Blood Pressure Change from Baseline | -5.20 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.77 |
| Sitting Diastolic Blood Pressure Change from Baseline | -2.19 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.77 |
| Incidence of Bronchitis | 2.3 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.117 |
| Incidence of Hepatic steatosis | 1.1 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.117 |
| Marketing authorization application submission date | 27 January 2017 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.7 |
| CHMP positive opinion date | 25 January 2018 | Merck & Co., Inc. — Segluromet EMA EPAR public assessment re, p.8 |
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.