FDA Approves SGLT2 Inhibitor Ertugliflozin for Type 2 Diabetes

Marlene Busko

December 21, 2017

The US Food and Drug Administration (FDA) has approved the sodium/glucose cotransporter 2 (SGLT2) inhibitor ertugliflozin (codeveloped by Merck and Pfizer) for glycemic control in adults with type 2 diabetes.

Ertugliflozin is approved as monotherapy (Steglatro, 5-mg and 15-mg tablets) to be taken once daily.

It is also approved as part of two fixed-dose combinations: with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin ( Steglujan ; available as 5-mg ertugliflozin/100-mg sitagliptin and 15-mg/100-mg) to be taken once daily and with metformin ( Segluromet ; 2.5-mg ertugliflozin/500-mg metformin; 2.5-mg/1000-mg; 7.5-mg/500-mg; and 7.5-mg/1000-mg) to be taken twice daily.

The new drug applications were accepted for review in March 2017 and were supported by studies from the VERTIS clinical development program for ertugliflozin, which consists of nine phase 3 trials in approximately 12,600 adults with type 2 diabetes.

Results from VERTIS MONO, VERTIS FACTORIAL, and VERTIS SITA2 were presented at medical congresses in 2016, and findings from VERTIS SU and VERTIS SITA2 were presented at the European Association for the Study of Diabetes (EASD) 2017 Annual Meeting in September 2017.

Fourth SGLT2 Inhibitor on Market in US

Ertugliflozin is the fourth SGLT2 inhibitor approved in the United States, following canagliflozin (Invokana, Janssen), dapagliflozin (Farxiga/Forxiga, AstraZeneca), and empagliflozin (Jardiance, Boehringer Ingelheim).

SGLT2 inhibitors work by increasing excretion of glucose in the urine. The most common adverse effect is female genital mycotic infections, and this is listed on the ertugliflozin label.

The drug class has also been associated with some rare side effects, including diabetic ketoacidosis, fracture risk, acute renal failure. and increased risk of toe amputation, although it's not clear whether these are class effects or not.

But overall these agents have been received enthusiastically, particularly since two, empagliflozin and canagliflozin, have shown cardiovascular benefit in large outcomes trials (EMPA-REG and CANVAS, respectively).

And on the basis of EMPA-REG, empagliflozin has also received an additional indication from the FDA for a CV mortality reduction.

Hence, the recently released American Diabetes Association 2018 Standards of Care now call for use of a glucose-lowering agent with cardiovascular benefit as second-line therapy in type 2 diabetes patients with established CVD who don't meet glycemic targets with lifestyle modification and metformin.

Cardiovascular outcomes trials with dapagliflozin (DECLARE) and ertugliflozin (VERTIS CV) are ongoing.

In a survey conducted recently by Medscape, only 45% of the 149 endocrinologists who responded had heard of ertugliflozin; 20% knew the name but little else about this agent.

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