Januvia gets thumbs up from CHMP

Merck, Sharp & Dohme, the UK subsidiary of Merck & Co, says that Januvia (sitagliptin), its treatment for type 2 diabetes, is the subject of a positive approval recommendation from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use.

The agent has been assessed as both a monotherapy and in combination with metformin in patients who struggle to achieve target blood sugar levels despite pre-existing metformin use plus appropriate diet and exercise. In addition, the product has been examined as an adjuvant to treatment with peroxisome proliferator-activated receptors gamma agonists such as thiazolidinedione in cases of diabetes mellitus.

MSD said that, if the drug is fully approved by the EMEA, it will be the first dipeptidyl peptidase-4 inhibitors to gain such status. The firm explained that DPP-4 inhibitors enhance the body's ability to lower blood sugar levels, thereby improving the levels of glycemic control that can be achieved. The firm added that Januvia is currently under review by the US Food and Drug Administration for use in similar type 2 diabetes indications.