INDIANAPOLIS (dpa-AFX) - Boehringer Ingelheim and Eli Lilly and Co. (LLY) on Wednesday announced the receipt of marketing authorization from the European Commission for Jentadueto tablets, a medicine combining the DPP-4 inhibitor, linagliptin and metformin in a single tablet taken twice daily.
The European Commission has approved Jentadueto for use alongside diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on their maximally tolerated dose of metformin alone, metformin and a sulfonylurea, or those already being treated with the combination of linagliptin and metformin.
Jentaduet may be used with a sulfonylurea, as well.
Jentadueto was approved by the U.S. Food and Drug Administration in January as a prescription medicine used along with diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin is appropriate.
The Jentadueto U.S. label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Jentadueto.
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