Segluromet

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On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Segluromet, intended for the treatment of type 2 diabetes. The applicant for this medicinal product is Merck Sharp & Dohme Limited.

Segluromet is a fixed dose combination of ertugliflozin and metformin, two oral blood glucose lowering medicines (ATC code: A10BD23). 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). Ertugliflozin works by blocking a protein in the kidney called the human sodium-glucose co-transporter-2 (SGLT2). This reduces glucose re-absorption in the kidney leading to glucose excretion in the urine. Metformin works by suppressing glucose production by the liver, by decreasing intestinal absorption of glucose, and by increasing peripheral glucose uptake and utilisation.

The benefit with Segluromet is its ability to lower blood glucose. The most common side effects are vulvovaginal mycotic infection and other female genital mycotic infections as well as gastrointestinal symptoms (nausea, vomiting, diarrhoea, abdominal pain and loss of appetite). Serious diabetic ketoacidosis occurs rarely.

The full indication is:

“Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:

  • in patients not adequately controlled on their maximally tolerated dose of metformin alone;
  • in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes;
  • in patients already being treated with the combination of ertugliflozin and metformin as separate tablets.

(For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5 and 5.1.)”

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Name Language First published Last updated
CHMP summary of positive opinion for Segluromet (English only) 2018-01-26  

Key facts

Product details for Segluromet
NameSegluromet
INN or common name

ertugliflozin / metformin

Therapeutic area Diabetes Mellitus, Type 2
Active substance

ertugliflozin l-pyroglutamic acid / metformin hydrochloride

Date opinion adopted25/01/2018
Company name

Merck Sharp & Dohme Limited

StatusPositive
Application typeInitial authorisation