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The European Commission has approved Januvia (sitagliptin) for two additional uses for patients with type 2 diabetes, the drug’s manufacturer Merck has announced.
It means the drug is the only dipeptidyl peptidase-4 inhibitor (DPP-4 inhibitor) approved as an add-on therapy to a sulphonylurea, or a sulphonylurea plus metformin, in the EU.
Sitagliptin, which is also the only DPP-4 inhibitor approved for once-daily use, was given the green light in the EU in March 2007 for the treatment of type 2 diabetes in combination with metformin or a peroxisome proliferator-activated receptor (gamma) agonist, such as thiazolidinedione.
The approval comes after phase III clinical trials showed that the addition of sitagliptin significantly reduces haemoglobin A1C (HbA1c) levels and fasting plasma glucose levels.
The only significant side-effects recorded are a stuffy or runny nose, sore throat, upper respiratory infection, and headaches.
Merck’s president in Europe, Middle East, Africa and Canada, Stefan Oschmann, said; “The approval of these new indications is another step forward in helping to combat type 2 diabetes.
“It is important because it provides physicians and patients with more options to achieve reduced glycaemic levels.”
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