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FDA Accepts NDA For Triple Combination Tablet For Adults With Type 2 Diabetes

Boehringer Ingelheim and Eli Lilly and Co. (LLY) announced Tuesday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the investigational fixed-dose triple combination tablet of empagliflozin, linagliptin and metformin extended release (XR) for the treatment of adults with type 2 diabetes.

The NDA is based on two randomized open-label trials that assessed the bioequivalence of empagliflozin, linagliptin and metformin XR investigational fixed-dose combination tablets and their individual components in healthy adults.

Boehringer Ingelheim and Lilly plan to present results from the trials at a medical congress later this year.

If approved by the FDA, the combination tablet would be one of the first single-pill options with three complementary mechanisms of action to help manage blood glucose in adults with type 2 diabetes who could benefit from having empagliflozin and linagliptin as part of their treatment regimen, in addition to metformin.

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