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Two type 2 diabetes drugs from Merck and Pfizer gain FDA approval




Pharmacies in the United States will soon stock two more medications for treating type 2 diabetes after pharmaceutical giants Merck and Pfizer had a pair of products approved by the US Food and Drug Administration (FDA). Steglujan (ertugliflozin and sitagliptin) and Steglatro (ertugliflozin) were both approved as adjunctive therapies to be used alongside dietary changes and exercise. 

Steglatro is indicated for the treatment of patients with type 2 diabetes mellitus as an adjunct to diet and exercise. It will be used to improve glycemic control in adults with type 2 diabetes but is not recommended for use in patients with type 1 diabetes. Steglujan is also indicated as a means of improving glycemic control when the use of both ertugliflozin and sitagliptin is appropriate. 

Diabetes affects more than 30 million people in the United States, around 9.4 percent of the population, according to the latest National Diabetes Statistics Report 2017 from the Centers for Disease Control and Prevention (CDC). Type 2 diabetes accounts for an estimated 95 percent of all cases of diabetes in the country.

James Rusnak, MD, senior vice-president and chief development officer, internal medicine at Pfizer Global Product Development, stated: “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.”

Approval of the Merck and Pfizer drugs was supported by seven Phase III studies, involving around 4,800 patients. Patients given Steglatro demonstrated significant A1C reductions when given the drug on its own or in conjunction with sitagliptin. Lowering A1C levels is a vital part of managing diabetes and in many cases, patients use multiple medications, (for example biguanides such as metformin, or DPP-4 inhibitors such as Onglyza (saxagliptin) or Tradjenta (linagliptin)) to achieve this. 

Over 2018, a number of new treatments and medications to help patients with diabetes have been approved by the FDA. Earlier this month, the agency approved a new short-acting follow-on insulin product called Admelog (insulin lispro) to improve control of blood sugar levels in adults and pediatric patients aged three and over who have type 1 diabetes, and for adults with type 2 diabetes mellitus.