Synjardy Approved for Use in Treatment-Naive T2DM Patients

The updated labeling includes data from a Phase 3, double-blind, randomized, active-controlled study
The updated labeling includes data from a Phase 3, double-blind, randomized, active-controlled study

Boehringer Ingelheim and Eli Lilly announced that the Food and Drug Administration (FDA) has approved the expanded use of Synjardy (empagliflozin, metformin HCl) to include treatment-naive adults with type 2 diabetes. 

Synjardy is currently 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. It combines empagliflozin (Jardiance), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and metformin, a biguanide. Empagliflozin works by removing excess glucose through the urine by blocking glucose reabsorption in the kidney. Metformin works by lowering glucose production in the liver and its absorption in the intestine. 

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The updated labeling for Synjardy includes data from a Phase 3, double-blind, randomized, active-controlled study that evaluated the safety and efficacy of empagliflozin in combination with metformin as initial therapy vs. the individual ingredients. At 24 weeks, empagliflozin 10mg or 25mg combined with metformin 1000mg or 2000mg led to significant reductions in A1c vs. the corresponding dose of either component alone. 

Synjardy is available as 5mg/500mg, 5mg/1000mg, 12.5mg/500mg, and 12.5mg/1000mg strength tablets in 60- and 180-count bottles. 

For more information call (800) 542-6257 or visit Synjardy.com.

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