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EC approves extra tumour indication for Novartis' Votubia

First drug approved in Europe for non-cancer tumours associated with TSC

Novartis has received European approval for the use of Votubia in the treatment of patients with non-cancerous kidney tumours associated with tuberous sclerosis complex (TSC).

The approval from the European Commission means Votunia (everolimus) is now the first drug available in the region for this subset of patients with TSC, with surgery the only previous option.

Kidney tumours (otherwise known as renal angiomyolipomas) affect up to 80 per cent of patients with TSC, a genetic disorder caused by a defect in the TSC1 and/or TSC2 genes that leads to increased activity of the mTOR protein.

When this protein is activated, it can cause uncontrolled tumour cell growth, blood vessel growth and altered cellular metabolism.

Votubia works by inhibiting the function of mTOR, reducing these effects. It uses the same active ingredient as the cancer drug Afinitor, which is one of Novartis' fastest-growing products and has received approvals in a number of oncology indications.

During phase III studies investigating Votubia's use in TSC patients with renal angiomyolipomas, 42 per cent of patients taking the product experienced a renal angiomyolipoma response, compared to 0 per cent in the placebo arm.

“For the first time, European patients living with renal angiomyolipomas associated with TSC now have an effective non-surgical option,” said Herve Hoppenot, president of Novartis' oncology business.

“This approval reinforces the potential of Votubia to treat a wide range of manifestations associated with TSC, a debilitating, lifelong disease where there remains critical unmet need.”

Votubia is already approved in Europe for the treatment of non-cancerous brain tumours associated with TSC, a disorder known as subependymal giant cell astrocytoma (SEGA).

TSC affects approximately one to two million people worldwide and is associated with a number of resulting disorders such as seizures and swelling in the brain. 

6th November 2012

From: Sales



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