US green light for Pfizer/Merck diabetes therapies

Pfizer and Merck’s diabetes drugs Steglatro and Steglujan have been approved for the US market.

Steglatro (ertugliflozin) is an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type II diabetes mellitus.

Steglujan is a fixed combination of ertugliflozin and sitagliptin, indicated as an adjunct to diet and exercise to boost glycaemic control in adults with type II diabetes when treatment with both ertugliflozin and sitagliptin is appropriate.

The approvals ride on data from seven Phase III studies involving around 4,800 patients, in which Steglatro was studied as monotherapy and in combination with metformin and/or sitagliptin, as well as with insulin and a sulfonylurea, in adults with type II diabetes and moderate renal impairment.

"In clinical trials, treatment with Steglatro resulted in significant A1C reductions when used alone or in combination with sitagliptin," said Juan Pablo Frias, president and principal investigator, National Research Institute, Los Angeles.

"This is important, as A1C-lowering is a key component of diabetes management, and many of my adult patients may need multiple medications to help manage their condition."

On the safety side, Steglatoro and Steglujan are contraindicated in patients with severe renal impairment, end-stage renal disease or on dialysis, or with a history of a serious hypersensitivity reaction to ertugliflozin. Steglujan is also contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin.

Pfizer and Merck, which is known as MSD outside of the US and Canada, formed an alliance to jointly develop and commercialise Pfizer’s ertugliflozin for the treatment of type II diabetes in 2013.