Bristol-Myers Squibb and AstraZeneca received approval from the FDA for Kombiglyze XR for the treatment of type 2 diabetes in adults. Kombiglyze XR is the first once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering glycemic control across glycosylated hemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).
Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. The approval was based on two Phase III trials and bioequivalence studies that evaluated the efficacy and safety of saxagliptin and metformin IR as separate tablets compared to placebo added to metformin IR. Bioequivalence was demonstrated in healthy adults between Kombiglyze XR and saxagliptin plus metformin XR as separate tablets.
“Nearly half of adult patients remain uncontrolled on their current treatment regimen and may thus require additional medications,” said Elliott Sigal, M.D., Ph.D, executive vice president, chief scientific officer, and president, R&D, BMS. “With our heritage of bringing metformin — the most widely prescribed oral antidiabetic medication — and more recently saxagliptin to patients in the U.S., we are committed to making Kombiglyze XR the newest building block in our long-term commitment to helping adult patients with type 2 diabetes.”