Another combination therapy for type 2 diabetes (T2DM) has entered the US market. On August 27, 2015, the FDA approved Synjardy, a combination of the sodium glucose cotransporter 2 (SGLT2) inhibitor, empagliflozin, and metformin hydrochloride. The new combination therapy was developed by Eli Lilly and Company and Boehringer Ingelheim Pharmaceuticals, who an-nounced the FDA action in a joint statement.
Synjardy is the third therapy that includes empagliflozin. The first such therapy was approved as a monotherapy and is sold as Jardiance. The second, Glyxambi, com-bines the SGLT2 inhibitor with linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.
SGLT2 inhibitors blocks the protein responsible for glucose reabsorption in the excretory system; thus, excess glucose is expelled through the urine. In this combination therapy, the SGLT2 inhibitor complements metformin, a longstanding treatment for T2D that lowers glucose production in the liver and its reabsorption in the intestines.
The FDA’s action is based on findings from earlier clinical trials that involved ad-ministration of empagliflozin and metformin in combination, either with or with-out sulfonylurea, to treat T2DM. The drug is currently available in Europe. Reference
US FDA approves Synjardy (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes [press release]. Ridgefield, CT, and Indianapolis, IN: PRNewswire; August 27, 2015. www.prnewswire.com/news-releases/us-fda-approves-synjardy-empaglifloz-inmetformin-hydrochloride-tablets-for-adults-with-type-2-diabetes-300134171.html. Accessed August 31, 2015.