FDA approves Kombiglyze XR

LONDON and PRINCETON, N.J. The Food and Drug Administration approved the first and only once-a-day metformin extended-release plus dipeptidyl peptidase-4 inhibitor combination tablet for the treatment of Type 2 diabetes.

Bristol-Myers Squibb and AstraZeneca's Kombiglyze XR offers strong glycemic control across HbA1c levels, fasting plasma glucose and post-prandial glucose. 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 drug companies said.

The FDA approved once-a-day Kombiglyze XR based on two phase-3 clinical trials and bioequivalence studies. The two clinical studies evaluated the efficacy and safety of saxagliptin and metformin IR as separate tablets compared with 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, EVP, chief scientific officer and president of research and development at Bristol-Myers Squibb. “With our heritage of bringing metformin -- the most widely prescribed oral antidiabetic medication -- and more recently saxagliptin to patients in the United States, we are committed to making Kombiglyze XR the newest building block in our long-term commitment to helping adult patients with Type 2 diabetes.”