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Pharma  Policies  Story
Novartis gets Japanese approval for three medicines

Singapore, Jan 20, 2010: Novartis has received Japanese drug regulator's nod to launch three medicines for Diabetes, high BP and kidney cancer.

Novartis said the Ministry of Health, Labor and Welfare (MHLW) approved the launch of Equa (vildagliptin), marketed as Galvus in the European Union, 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 the 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. As a DPP-4 inhibitor, Equa works by targeting the dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes.


Exforge has been approved in Japan as a single-pill combination of two treatments for high blood pressure: Diovan (valsartan), the number one selling hypertension medication worldwide, and amlodipine, the world's most prescribed calcium channel blocker.


Afinitor (everolimus) in tablet form has been approved in Japan for the treatment of patients with non-resectable, metastatic renal cell carcinoma (advanced kidney cancer). Each year, more than 10,000 people in Japan are diagnosed with kidney cancer.

© BioSpectrum Bureau
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