FDA Approves Type 2 Diabetes Drug


Treatment has complementary actions that help control blood glucose.

Treatment has complementary actions that help control blood glucose.

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.

Related Videos
Pharmacist holding medicine box in pharmacy drugstore. | Image Credit: I Viewfinder - stock.adobe.com
Pharmacy Drugstore Checkout Cashier Counter | Image Credit: Gorodenkoff - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Capsules medicine and white medicine bottles on table | Image Credit: Satawat - stock.adobe.com
Human cell or Embryonic stem cell microscope background | Image Credit: Anusorn - stock.adobe.com
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg - stock.adobe.com
Biosimilar pharmaceutical drug bottle on blue background. | Image Credit: Carl - stock.adobe.com
Pharmaceutical manufacture background with glass bottles with clear liquid on automatic conveyor line. | Image Credit: wacomka - stock.adobe.com
Bottle and scattered pills on color background, top view | Image Credit: New Africa - stock.adobe.com
pharmacy | Image Credit: Diego Cervo - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.