EMA Advisory Panel Greenlights New Diabetes Treatments

Miriam E. Tucker

January 26, 2018

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended for approval three formulations of the sodium-glucose cotransporter-2 (SGLT2) inhibitor ertugliflozin, for type 2 diabetes, and a biosimilar of insulin glargine.

The decisions were made during the CHMP's January 25 meeting.

The three ertugliflozin formulations are manufactured by Merck Sharp & Dohme Ltd. All are indicated for adults aged 18 years and older with type 2 diabetes as adjuncts to diet and exercise to improve glycemic control.

Ertugliflozin monotherapy (Steglatro) is indicated in patients for whom the use of metformin is considered inappropriate because of intolerance or contraindications, or in addition to other medications for the treatment of diabetes. It will be available as 5-mg and 15-mg film-coated tablets.

Fixed-dose ertugliflozin and metformin (Segluromet) is indicated in patients whose condition is not adequately controlled on their maximally tolerated dose of metformin alone, those who are taking their maximally tolerated doses of metformin in addition to other diabetes medications, and in patients already being treated with the combination of ertugliflozin and metformin as separate tablets. It will be available as film-coated tablets (containing 2.5 mg ertugliflozin/1000 mg metformin; 2.5 mg/850 mg; 7.5 mg/1000 mg; and 7.5 mg/850 mg).

Fixed-dose ertugliflozin and sitagliptin (Steglujan) is indicated when metformin and/or a sulfonylurea plus either ertuglifozin or sitagliptin alone do not provide adequate glycemic control, and in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets. The new combination will be available as film-coated tablets containing either 5 mg ertugliflozin and 100 mg sitagliptin, or 15 mg ertugliflozin and 100 mg sitagliptin.

The most common side effects of the ertugliflozin component are vulvovaginal mycotic infection and other female genital mycotic infections. Serious diabetic ketoacidosis occurs rarely.

All three ertugliflozin formulations were approved by the US Food and Drug Administration in December 2017.

Another New Biosimilar Insulin Also Recommended

CHMP has also recommended granting marketing authorization for the glargine biosimilar Semglee (Mylan SAS), a basal insulin analogue indicated for the treatment of diabetes in adults, adolescents, and children aged 2 years and older. It will be available as a 100-units/mL solution.

The new product is similar to the branded insulin glargine (Lantus, Sanofi), which was authorized in the EU in June 2000. Data show that the new product has "comparable quality, safety, and efficacy to Lantus."

Another glargine biosimilar made by Lilly and Boehringer Ingelheim (Abasaglar) was approved in the EU in 2014. In the United States, where such products are called "follow-ons," it was approved as Basaglar in December 2015.

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