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Jan 20, 2010

Japan Sanctions Three Novartis Drugs for Hypertension, Advanced Renal Cancer, and Type 2 Diabetes

  • Japanese regulatory authorities sanctioned three Novartis drugs: Exforge® for high blood pressure, Afinitor® (everolimus) for advanced kidney cancer, and Equa® (vildagliptin) as an oral therapy for type 2 diabetes.

    Exforge is a single-pill combination of Diovan® (valsartan) and the calcium-channel blocker amlopidine. The drug made global sales of $475 million during the first nine months of 2009, up 81% on same period in 2008. It ranked as Novartis’ 10th top-selling pharmaceutical.

    Afinitor’s go-ahead in Japan follows on EU approval of the drug in April 2009 and FDA clearance in March 2009. Afinitor achieved global sales of $38 million during the first nine months of 2009, according to Novartis.

    Phase III studies with Afinitor are also under way in patients with neuroendocrine tumors, breast cancer, lymphoma, tuberous sclerosis complex, and gastric cancer. A late-stage trial is planned to start in patients with hepatocellular carcinoma during early 2010.

    Equa is marketed as Galvus® in the EU. First launched in 2008, Galvus is now approved in some 70 countries. It made sales of $115 million in the first three quarters of 2009, up 416% in local currencies. Eucreas, a single-pill combination of Galvus with the oral antidiabetes medicine metformin, is approved in 50 countries.


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