Home Fairfield FDA accepts new diabetes drug application from Boehringer Ingelheim and Eli Lilly

FDA accepts new diabetes drug application from Boehringer Ingelheim and Eli Lilly

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A bit of good news might be coming soon for the 425 million people worldwide with type 2 diabetes who have to take multiple medicines to control their condition. It was announced this morning that the U.S. Food and Drug Administration has accepted a new drug application by Ridgefield-based Boehringer Ingelheim and Eli Lilly and Co. for a fixed-dose combination tablet.

Boehringer Ingelheim Vanderbilt University anticancer“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,” said Dr. Mohamed Eid, vice president of clinical development and medical affairs for Boehringer Ingelheim Pharmaceuticals Inc.

The new drug application 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,” according to the two pharmaceutical companies. Boehringer Ingelheim and Lilly plan to present results from the trials at a medical congress later this year.

“We look forward to working with the FDA to make this combination tablet of empagliflozin, linagliptin and metformin XR available in hopes that it may help adults with type 2 diabetes better manage their condition with their healthcare providers,” said Dr. Sherry Martin, vice president of medical affairs at Lilly.

Empagliflozin is sold as Jardiance, a prescription medicine that removes excess glucose through the urine by blocking glucose reabsorption in the kidney. It is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes and is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

Linagliptin, marketed as Tradjenta, controls glucose by increasing hormones that stimulate the pancreas to secrete insulin and stimulate the liver to produce less glucose. It also is a once-daily tablet used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

Metformin is the most commonly prescribed initial treatment for type 2 diabetes. It decreases the production of glucose in the liver and its absorption in the intestine and improves the body’s sensitivity to insulin and ability to utilize glucose.

About 30 million Americans have diabetes with more than 7 million undiagnosed, according to Boehringer. In the U.S., approximately 12% of those aged 18 and older have diabetes.

 

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