In December 2017, ertugliflozin (Steglatro™), developed by Merck and Pfizer, received its first global approval in the US for use in conjunction with exercise and diet to improve glycaemic control in adults with type-2 diabetes mellitus (T2DM). [1

At the same time the FDA also approved a fixed dose combination tablet formulation of ertugliflozin and sitagliptin (Steglujan™)[2] for the same indication, where use of each agent is appropriate. [3]

Subsequently in January 2018 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended the Marketing Authorisation for fixed dose ertugliflozin plus metformin (Segluromet™)[4] tablets be granted, also for use in conjunction with exercise and diet to improve glycaemic control in adults with T2DM. [5]

Ertugliflozin is an orally active sodium glucose co-transporter type 2 (SGLT2) inhibitor. SGLT2 is responsible for 90% of kidney reabsorption of glucose. Therefore, by inhibiting it, there will be an increase in urinary excretion of glucose resulting in a lower blood glucose level and an increased glycaemic control. [1]

It is well known that the incidence of diabetes is rising – both type 1 and type 2 and not only in adults. Lifestyle and dietary habits can make a difference particularly in T2Dm, but sometimes additional help is required.

“There remains a need to help adults with type 2 diabetes improve their glycemic control, and as the prevalence of the disease continues to rise, we are pleased to offer additional treatment options to these patients and the healthcare providers who treat them,” said James Rusnak, M.D., Ph.D., senior vice president and chief development officer, internal medicine, Pfizer Global Product Development. [3]

The FDA approvals for ertugliflozin alone and as a combination product were supported by evidence from about 4,800 patients who took part in seven phase III studies in which significant reductions in hemoglobin A1C levels were observed in recipients of the agent. [3]

“This is important,” said Juan Pablo Frias, M.D., president and principal investigator, National Research Institute, Los Angeles, “ as A1C-lowering is a key component of diabetes management.” [3]

The prescribing information for ertugliflozin carries warnings that include risk of hypotension, ketoacidosis, acute kidney injury and renal impairment, and states that the most common adverse event associated with its use is genital mycotic infections. [6]

The recent first global approval of ertugligflozin has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[7].

 

Image credit:  Justyn Warner on Unsplash

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