Novel Diabetes Drug Approved by FDA

Eli Lilly and Company announced the FDA on Monday approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) for the treatment of patients with type 2 diabetes.

When used with diet and exercise, Synjardy XR can improve blood sugar control in these patients, according to a press release from Lilly. The drug is co-marketed by Lilly and Boehringer Ingelheim.

Maintaining blood sugar control is important for patients with type 2 diabetes, since uncontrolled blood glucose levels can potentially cause serious health effects. Approximately 415 million people worldwide have diabetes, with 29 million individuals living in the United States.

Synjardy XR is a combination of empagliflozin and metformin, which have complementary mechanisms of action. Empagliflozin is a sodium-glucose co-transporter 2 inhibitor that removes surplus glucose through the urine by inhibiting re-absorption in the kidney, according to Lilly. Metformin is a commonly used diabetes treatment that lowers glucose production and absorption.

The recent approval is based on positive findings from multiple clinical trials that analyzed the co-administration of empagliflozin and metformin. These clinical trials also studied the drugs as a monotherapy, or plus sulfonylurea in patients with type 2 diabetes.

While the drug is effective in patients with type 2 diabetes, Lilly warns that it is not indicated in patients with type 1 diabetes or diabetic ketoacidosis, and these patients should not use Synjardy XR.

Synjardy XR can potentially cause serious side effects, such as lactic acidosis, where lactic acid accumulates in the blood. A component of Synjardy XR, metformin, is known to cause this potentially life-threatening side effect.

The risk of developing lactic acidosis could be a reason why physicians are underusing this drug as a first-line treatment for patients with type 2 diabetes, as some studies have suggested.

Synjardy XR can also cause dehydration, low blood pressure, and ketoacidosis, according to the press release.

"Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition," said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals, Inc. "With Synjardy XR, the eighth FDA-approved treatment to emerge from our partnership with Lilly, adults with type 2 diabetes now have 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."