Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.AstraZeneca and Bristol-Myers Squibb Company's (BMS) Kombiglyze XR has received approval from the US Food and Drug Administration (FDA) for the treatment of type 2 diabetes in adults.
Subscribe to our email newsletter
Kombiglyze XR is a once-a-day metformin extended-release (XR) plus dipeptidyl peptidase-4 (DPP-4) inhibitor combination tablet offering glycaemic control across glycosylated haemoglobin levels (HbA1c), fasting plasma glucose (FPG) and post-prandial glucose (PPG).
Kombiglyze XR is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin (also known as Onglyza), and metformin is appropriate.
Once-a-day Kombiglyze XR is known to combine saxagliptin, a DPP-4 inhibitor, and metformin XR, a biguanide, in one tablet for the treatment of type 2 diabetes.
AstraZeneca chief medical officer Howard Hutchinson said that Kombiglyze XR combines two diabetes medications in a simple once-a-day dose for adult patients who need A1c reductions.
Kombiglyze XR has been approved by the FDA based on two Phase III clinical trials and bioequivalence studies which 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.
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to enable the companies to research, develop and commercialise select investigational drugs for type 2 diabetes.