FDA Accepts NDA of BI’s and Eli Lilly’s Combination Diabetes Drug

The US Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination, an investigational compound being studied for the treatment of adults with Type 2 diabetes. Empagliflozin plus metformin is part of the diabetes alliance between Boehringer Ingelheim and Eli Lilly.  

Empagliflozin is a sodium glucose co-transporter-2 inhibitor, which removes excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin, a commonly prescribed initial treatment for Type II diabetes, decreases the production of glucose in the liver and its absorption in the intestine and improves the body’s ability to utilize glucose.

Empagliflozin, marketed as Jardiance (empagliflozin) tablets in the US was approved by the FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes.

Source: Eli Lilly

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