U.S. FDA Accepts NDA for Triple-Combination Tablet with Three Complementary Mechanisms for Type 2 Diabetes
Jun 07, 2019 10:07
CST Updated
10:07
Boehringer Ingelheim
Developer of Innovative Drugs and Therapies
Eli Lilly
Global Pharmaceutical R&D and Production Company
FDA
U.S. Food and Drug Administration
June 07, 2019 News /BioValleyBIOON/ -- Boehringer Ingelheim-Eli LillyDiabetesThe alliance recently announced that the United StatesFDAAccepted: Empagliflozin/Linagliptin/Metformin Extended-Release (XR) Fixed-Dose Combination Tablets for the Treatment of Type 2 DiabetesDiabetesNew Drug Application (NDA) for adult patients. This NDA is based on two randomized, open-label studies evaluating the bioequivalence of empagliflozin/linagliptin/metformin XR fixed-dose combination tablets and their individual components in healthy adults. Boehringer Ingelheim andEli LillyPlanned for the medical conference to be held later this yearConferencepublish the results of these studies on
Empagliflozin (Jardiance) is sold in the United States under the brand name Jardiance. This medication is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor that works by blocking glucose reabsorption in the kidneys, thereby excreting excess glucose through urine to lower blood sugar levels. Its glucose-lowering effect does not depend on β-cell function or insulin resistance. Jardiance is a once-daily tablet used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.DiabetesGlycemic control in patients, and for type 2 diabetes with comorbid cardiovascular diseaseDiabetesThe patient reduces the risk of cardiovascular death. This drug is not suitable for patients with type 1 diabetes or diabetic ketoacidosis.
Linagliptin (Tradjenta) is sold in the United States under the brand name Tradjenta. This medication is a dipeptidyl peptidase-4 (DPP-4) inhibitor that controls blood glucose by increasing hormones that stimulate the pancreas to secrete insulin and stimulate the liver to produce less glucose. Tradjenta is a once-daily 5 mg tablet used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The long-term cardiovascular safety of Tradjenta has been evaluated in two independent cardiovascular outcome trials involving adult patients with type 2 diabetes mellitus who are at increased cardiovascular risk. Tradjenta is not indicated for the treatment of patients with type 1 diabetes mellitus or diabetic ketoacidosis. Tradjenta has not been studied in patients with a history of pancreatitis.
Metformin is the most commonly used initial treatment for type 2 diabetes. It reduces hepatic glucose production and intestinal absorption, while enhancing insulin sensitivity and the body's ability to utilize glucose.
Mohamed Eid, Vice President of Clinical Development and Medical Affairs at Boehringer Ingelheim, stated, “Currently, adult patients with type 2 diabetes need to take multiple medications to manage their condition. If approvedFDA“Approval granted; this triple-combination tablet will become one of the first single-tablet options featuring three complementary mechanisms of action, helping patients with type 2 diabetes more effectively manage their blood glucose levels, improve overall care, and enhance prognosis.”(Bioon.com)