Astra Zeneca — Qtern EMA EPAR public assessment report (EMEA/H/C/004057, 2016)

Report summary

The EMA assessed Qtern, a fixed-dose combination of saxagliptin (5mg) and dapagliflozin (10mg), for Type 2 Diabetes Mellitus. The report confirms acceptable quality, leveraging prior development of individual components. Non-clinical studies found no unexpected interactions or toxicities. Clinical trials demonstrated significant reductions in HbA1c, FPG, and body weight with the triple combination (Qtern + metformin) compared to dual therapies, primarily at Week 24. While effective, the additional clinical benefit of saxagliptin when added to dapagliflozin + metformin was considered limited, especially at higher baseline HbA1c. The safety profile was consistent with individual components, showing low hypoglycemia rates and no new safety concerns, though UTIs and vulvovaginal mycotic infections were noted in females. Ongoing pharmacovigilance studies continue to monitor safety.

Key findings — cited to the page