The latest option combines empagliflozin and metformin hydrochloride.
Another combination therapy for type 2 diabetes mellitus (T2DM) has entered the US market with FDA’s approval August 27, 2015, of Synjardy, which includes an SGLT2 inhibitor, empagliflozin, and metformin hydrochloride.
Synjardy is the third therapy that includes empagliflozin; which was approved as a monotherapy and is sold as Jardiance, and as Glyxambi, which combines the SGLT2 inhibitor with linagliptin, a DPP-4 (dipeptidyl peptidase-4) inhibitor.
The new combination therapy was developed by Eli Lilly Company and Boehringer Ingelheim Pharmaceuticals; the companies announced the FDA action in a joint statement.
Sodium glucose cotransporter-2 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 treatement for T2DM that lowers glucose production in the liver and its reabsorption in the intestines.
FDA’s action is based on findings from earlier clinical trials that involved administration of empagliflozin and metformin in combination, either with or without sulfonyfurea, to treat T2DM. The drug is already available in Europe.
US FDA approves Synjardy (empagliflozin/metformin hydrochloride) tablets for adults with type 2 diabetes [press release]. http://www.prnewswire.com/news-releases/us-fda-approves-synjardy-empagliflozinmetformin-hydrochloride-tablets-for-adults-with-type-2-diabetes-300134171.html Ridgefield, CT, and Indianapolis, IN: PRNewswire; August 27, 2015.