FDA approves SGLT2 inhibitor ertugliflozin and combo with sitagliptin

26 December 2017

The US Food and Drug Administration has approved Steglatro (ertugliflozin) tablets, an oral sodium-glucose co-transporter 2 (SGLT2) inhibitor, and the fixed-dose combination Steglujan (ertugliflozin and sitagliptin) tablets, which have been developed by US pharma giants Merck & Co (NYSE: MRK) and Pfizer (NYSE: PFE).

Steglatro is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Steglujan is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. Neither drug is recommended in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

The newly-approved SGLT2 inhibitor diabetes treatments will compete with compete with AstraZeneca’s (LSE: AZN) Farxiga (dapagliflozin), Johnson & Johnson’s Invokana (canagliflozin) and Eli Lilly (NYSE: LLY) and Boehringer Ingelheim’s Jardiance (empagliflozin). Merck and Pfizer expect to launch the drugs in early 2018.

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