Merck & Co., Inc. — Segluromet EMA EPAR public assessment report (EMEA/H/C/004314, 2018)

Report summary

Merck Sharp & Dohme Limited's Segluromet (ertugliflozin/metformin hydrochloride) received a positive CHMP opinion for EU marketing authorization in January 2018, for improving glycemic control in adults with type 2 diabetes. The application, supported by extensive non-clinical and clinical data, demonstrated the product's quality, stability, and bioequivalence. Non-clinical studies confirmed the safety profile of ertugliflozin, with most effects linked to its pharmacological action. Environmental risk assessment found neither active substance to be PBT or vPvB. Pharmacokinetic and pharmacodynamic studies detailed the drug's absorption, distribution, metabolism, and elimination, and its impact on urinary glucose excretion and HbA1c. Multiple Phase 3 clinical trials consistently showed significant reductions in HbA1c, fasting plasma glucose, and body weight, with improvements in blood pressure. Safety evaluations identified increased rates of genital infections and hypoglycemia, consistent with other SGLT2 inhibitors, and these risks are addressed in the Risk Management Plan.

Key findings — cited to the page