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Novartis' Votubia brain tumour drug recommended for EU approval

Published: 02:58 25 Jun 2011 AEST

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Novartis (NYSE:NVS) announced Friday its everolimus drug, marketed as Votubia outside the U.S., has been recommended by the European Medicines Agency (EMA) for approval in the European Union (EU).

The drug is designed for use by children and adults with subependymal giant cell astrocytoma (SEGA), a type of benign brain tumour associated with tuberous sclerosis complex (TSC). Candidates for the drug are patients who require therapeutic treatments, but are not suitable for surgery.

If approved, Votubia will be the first medication for this disease in the EU, where surgery is currently the only treatment available.

Affecting between one and two million people worldwide, TSC is a genetic disorder that causes an increase in the activity of the mTOR protein, resulting in uncontrolled tumour cell growth and altered cell metabolism, leading to the development of benign tumours throughout the body.

Novartis' Votubia drug inhibits mTOR activity, reducing tumour cell growth.

EMA's positive opinion is based on the results of the phase two study of the drug, which saw 78% of patients experience a 30% or greater reduction in the size of benign tumours. No patients developed new tumours or required surgery or other treatments while receiving the Votubia drug.

The Basel, Switzerland-based company said it expects a final decision within three months, which, if successful, will be applicable to all 27 countries in the EU.

Novartis already markets the everolimus drug in the U.S. and Europe under the brand name Afinitor as a treatment for kidney cancer.

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