US-based pharmaceutical company Merck has received US Food and Drug Administration (FDA) approval for Janumet XR, its new type 2 diabetes treatment.
Janumet XR combines sitagliptin, the active component of Januvia, with extended-release metformin in order to provide a once-daily treatment option for patients needing to control their blood sugar.
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The drug received approval based upon the results of a clinical bioequivalence study, which demonstrated that the use of Janumet XR was equivalent to co-administration of corresponding doses of sitagliptin and metformin HCI extended-release.
Merck Diabetes and Endocrinology vice president, Barry Goldstein, said: "This is important because many patients with type 2 diabetes require treatment with multiple drugs to maintain blood sugar control, and Janumet XR is a new option to help more patients get to their glucose goals."
The drug will come with a boxed warning for lactic acidosis, a rare complication that can occur due to metformin accumulation.
Janumet XR has also not been studied in patients with a history of pancreatitis, and it is not yet known whether patients with a history of the illness are at an increased risk of developing pancreatitis whilst using the drug.
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By GlobalData
