Type 2 Diabetes Treatment Synjardy Approved by FDA

A new type 2 diabetes (T2D) treatment for adult patients, empagliflozin and metformin (Synjardy), was approved by the FDA today.

Synjardy, from Boehringer Ingelheim (BI) Pharmaceuticals and Eli Lilly and Company, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. The tablets are not appropriate for type 1 diabetes or diabetic ketoacidosis.

The diabetes drug carries a boxed warning for risk of lactic acidosis due to metformin accumulation.

Synjardy’s FDA approval was based on clinical trials testing coadministration of empagliflozin and metformin, alone or in combination with sulfonylurea, among adults with type 2 diabetes.

The 2 medicines contained in Synjardy have complementary actions that help control blood glucose, according to the FDA. Empagliflozin removes excess glucose through urine by blocking glucose reabsorption in the kidney, while metformin lowers glucose production by the liver and absorption in the intestine, the FDA noted.

This is the third product containing empagliflozin that has been approved by the FDA, following nods for Jardiance and Glyxambi.

“Synjardy is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last 4 years,” Paul Fonteyne, president and CEO of BIPI, said in a press release. "No 2 people with diabetes are alike, and every experience is different. Our alliance is proud to offer a diverse portfolio of treatments that can help patients throughout their diabetes journey.”

Diabetes affects around 29 million Americans, and approximately 90% to 95% of adults who have been diagnosed have type 2 diabetes, according to the FDA.