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Novartis medicines approved in Japan

New drugs for patients with type 2 diabetes, high blood pressure and advanced kidney cancer provide new treatment options for Japanese

Patients in Japan will benefit from the approval of three new Novartis medicines. These are Equa (vildagliptin), marketed as Galvus in the European Union (EU), for the treatment of type 2 diabetes, Exforge (valsartan/amlodipine) for high blood pressure, and Afinitor (everolimus) for advanced kidney cancer.

"It is a significant achievement to secure the approval of three such important new medicines for the benefit of Japanese patients," said Joe Jimenez, CEO of Novartis pharmaceuticals division. "These approvals, which follow six launches last year, mean we continue to quickly introduce innovative medicines to treat serious and life-threatening diseases affecting millions of Japanese patients and their families."

Equa has been approved in Japan for the treatment of type 2 diabetes, as monotherapy or in combination with a sulfonylurea. It works by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes and has been approved for doses of 50mg twice daily, or 50mg once daily.

Exforge has been approved as a single-pill combination of two treatments for high blood pressure: Diovan (valsartan) and amlodipine. It has been shown to be effective across all grades of high blood pressure, with as many as nine out of 10 Exforge patients reaching their blood pressure goal.

Afinitor (everolimus) in tablet form has been approved for the treatment of patients with non-resectable, metastatic renal cell carcinoma. A once-daily therapy, it provides continuous inhibition of the mTOR protein, a central regulator of tumour cell division and blood vessel growth in cancer cells. It is the first mTOR inhibitor approved to treat advanced kidney cancer patients in Japan.

Japan took part in the pivotal, international, phase III trial for Afinitor on which the approval was based. The trial, RECORD-1 (Renal Cell cancer treatment with Oral RAD001 given Daily), included patients from 14 trial sites across Japan and showed that Afinitor, when compared with placebo, more than doubled the median time without tumour growth or death in patients with advanced kidney cancer whose disease progressed following earlier vascular endothelial growth factor (VEGF)-targeted therapy.

This is the third major approval for Afinitor in less than a year, following approvals in the EU and US.

20th January 2010

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