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Eli Lilly and Co. and Boehringer Ingelheim GmbH said the U.S. Food and Drug Administration accepted their new drug application for a diabetes combination therapy.
The companies are seeking the approval of an investigational fixed-dose combination tablet of empagliflozin, linagliptin and metformin extended release to treat adults with type 2 diabetes.
Empagliflozin, sold by the companies as Jardiance in the U.S., is a once-daily tablet for lowering blood sugar in adults with type 2 diabetes. The drug is indicated to reduce the risk of cardiovascular death in type 2 diabetes patients with known heart disease.
Linagliptin is marketed as Tradjenta tablets in the U.S. and is also used to lower blood sugar in type 2 diabetes adult patients.
Metformin, the most commonly prescribed initial treatment for type 2 diabetes, works by decreasing sugar production in the liver and its absorption in the intestine. Metformin is sold by Bristol-Myers Squibb Co. as Glucophage.
"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," Mohamed Eid, Boehringer Ingelheim's vice president for clinical development and medical affairs, said in a statement.
The application is based on two randomized open-label studies that evaluated the similarities of empagliflozin, linagliptin and metformin extended release investigational fixed-dose combination tablets and their individual components in healthy adults. Indianapolis-based Lilly and Germany's Boehringer Ingelheim plan to present results from the trials at a medical congress later in 2019.