FDA Approves new combination drug to treat diabetes

The FDA as given marketing approval to AstraZenica and Brystol Myers Squibb for their new combination product Kombiglyze XR. Kombiglyze XR is a once daily dose of extended-release metformin and saxaglyptin. Saxaglyptin was previously approved by itself as Onglyza. Saxaglyptin is a member of the new class of anti-diabetic drugs called dipeptidyl peptidase-4 inhibitors, of which Merck’s Januvia/Janumet may be a more familiar member. The drug will compete in the already crowded but important marketplace of oral therapies for type-2 diabetes. Both of the DPP-4 inhibitors and their metformin combinations are top-tier and require prior authorization on popular health plans such as Priority Health and Blue Cross/Blue Shield of Michigan.


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