New Oral Ertugliflozin For T2D Approved by FDA

— OK'd in single and fixed-dose combo therapies

by Kristen Monaco, Staff Writer, �鶹��ý December 21, 2017

This article is a collaboration between �鶹��ý and:

Another SGLT2 inhibitor, ertugliflozin (Steglatro), was approved for glycemic control in adults with type 2 diabetes, the .

The once-daily, single therapy oral agent was approved as an adjunct to diet and exercise and will be available in two doses -- 5-mg and 15-mg tablets. Ertugliflozin was co-developed by long-time rivals Merck and Pfizer.

The approval also extends to two ertugliflozin combination treatments, including combination sitagliptin (Merck's Januvia) to be sold under the brand name Steglujan, as well as combination metformin (Segluromet) therapy. Steglujan will be available in two, once-daily fixed doses, including 5-mg ertugliflozin/100-mg sitagliptin and 15-mg/100-mg. Segluromet will be available in four, twice-daily fixed doses, including 2.5-mg ertugliflozin/500-mg metformin, 2.5-mg/1000-mg, 7.5-mg/500-mg, and 7.5-mg/1000-mg.

Tested as part of the VERTIS clinical development program, the combination therapy approvals are based upon two of the phase III studies from the program -- VERTIS MET (plus metformin) and VERTIS SITA (plus sitagliptin) -- which were presented earlier this year at the American Diabetes Association annual conference. The studies found a significant improvement in HbA1c compared to placebo, as well as weight loss and improvements in fasting plasma glucose and blood pressure.

Ertugliflozin is the fourth in a growing class of SGLT-2 inhibitors that also includes dapagliflozin (Farxiga), empagliflozin (Jardiance), and canagliflozin (Invokana).

Kristen Monaco is a senior staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.