US regulators have issued a green light for Boehringer Ingelheim and Eli Lilly’s new combination diabetes therapy Synjardy.
The US Food and Drug Administration says the drug - a fixed-dose combination of empagliflozin and metformin - can be used as an ajunct to diet and exercise to control blood sugar levels in patients with type II diabetes.
The pill’s two components 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 firms are hoping that the single tablet approach will boost treatment compliance and help patients better manage the condition.
Synjardy is the third empagliflozin-containing product approved by the FDA thus far. It’s label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with the therapy.
The combo, which received a European nod in May, 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.