FDA Approves Combination Diabetes Drug Synjardy XR

Synjardy XR, a combination of empagliflozin and metformin hydrochloride, was approved this afternoon by the FDA for glucose management in type 2 diabetics. The drug is a collaboration between Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company.

The US Food and Drug Administration (FDA) today approved Synjardy XR tablets for the treatment of type 2 diabetes in adults.

The drug, marketed by Boehringer Ingelheim and Eli Lilly and Company, is a combination of empagliflozin and metformin hydrochloride. Empagliflozin reduces excess glucose by blocking its re-absorption into the kidney, allowing it to be expelled in urine. Metformin lowers the liver’s glucose production, and is commonly prescribed as an early type 2 diabetes treatment.

As a single-tablet daily option, the goal of the drug is to consolidate medications for patients. President and CEO of Boehringer Ingelheim Paul Fonteyne said Synjardy XR would provide adults with type 2 diabetes “another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment." He highlighted that this was the eighth FDA-approved product to come from his company’s collaboration with Lilly.

Less than two weeks ago, the FDA approved Boehringer Ingelheim’s Jardiance, another empagliflozin treatment, for use in reducing cardiovascular mortality in type 2 diabetes patients, citing that it was “shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care therapies for diabetes and atherosclerotic cardiovascular disease.”

The new combination drug is not without risk. Empagliflozin can contribute to dehydration, low blood pressure, ketoacidosis, and urinary tract infections. Metformin, meanwhile, can cause lactic acidosis, the rare but serious condition that causes lactic acid buildup in the blood, which can be fatal.

The announcement was issued this afternoon in a press release.

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