Vokanamet: Metformin/Canagliflozin Combo Approved in EU

The fixed-dose combination therapy canagliflozin/metformin (Vokanamet, Janssen-Cilag International NV) has been approved in the European Union for the treatment of type 2 diabetes, the company has announced.

The new treatment was recommended for approval by the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) in February.

The combination therapy, which is taken as a single pill twice daily, is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycemic control in:

  • Patients not adequately controlled on their maximally tolerated doses of metformin alone.

  • Patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products, including insulin, when these do not provide adequate glycemic control.

  • Patients already being treated with the combination of canagliflozin and metformin as separate tablets.

Both components of the drug lower blood glucose, but they do so by different modes of action. Canagliflozin causes the kidney to excrete glucose in the urine by blocking a renal protein called human sodium-glucose cotransport 2 (SGLT-2). Metformin suppresses glucose production by the liver.

The drug will be available in tablets containing 4 amounts of canagliflozin/metformin: 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg, and 150 mg/1000 mg.

The US Food and Drug Administration has approved both drugs for use alone but declined to recommend the combination of metformin and canagliflozin in January 2014, asking for more data.

Another combination SGLT-2-inhibitor/metformin product (Xigduo, AstraZeneca/Bristol-Myers Squibb), this one containing dapagliflozin, is also available in Europe.

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