US regulators have agreed to review Eli Lilly/Boehringer Ingelheim’s empagliflozin/metformin fixed-dose combination as a potential treatment for patients with type II diabetes.
The two components of the therapy have very different modes of action: empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor that removes excess glucose through the urine by blocking glucose reabsorption in the kidney, while metformin decreases the production of glucose in the liver and its absorption in the intestine and improves the body's ability to utilise glucose.
The FDA's acceptance of the New Drug Application “brings us one step closer to offering a potential new treatment option that may help patients better manage their type 2 diabetes through one pill that combines two distinct approaches to help control blood sugar,” noted Christophe Arbet-Engels, head ofmetabolic-clinical development and medical affairs at the German drugmaker, explaining the rationale for the drug.
Empagliflozin is marketed as Jardiance on both sides of the Atlantic, having been approved in the EU and US this year as an adjunct to diet and exercise to improve glycaemic control in adult type II diabetics.
The combo is part of the BI/Eli Lillydiabetes alliance portfolio, born from a multi-million dollar pact signed in 2011 to develop innovative treatments for the disease.