The US Food and Drug Administration has approved an expanded indication for a combination product comprised of metformin and empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), known as Synjardy (Boehringer Ingelheim/Lilly), to allow use of the product in treatment-naive adults with type 2 diabetes.
The agent is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and metformin is appropriate.
The Synjardy label was updated to include results from a phase 3, double-blind, randomized, active-controlled study that evaluated the efficacy and safety of empagliflozin in combination with metformin as initial therapy compared with the individual components. In the study, at 24 weeks, the combination of empagliflozin 10 mg or 25 mg with metformin 1000 mg or 2000 mg resulted in significant reductions in HbA1c compared with the corresponding dose of either component alone, note the companies in a press release.
Metformin is indicated as first-line therapy in type 2 diabetes and empagliflozin, a newer sodium-glucose cotransporter-2 (SGLT-2) inhibitor, has gained traction for use in diabetes following the landmark results of the EMPA-REG trial.
An FDA advisory committee last month gave its backing to a new labeling claim, that of reduced cardiovascular mortality for empagliflozin, based on the results of the EMPA-REG trial.