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EC approval for Novartis' SEGA drug

Novartis' Votubia (everolimus), a treatment for SEGA associated with TSC, has been approved by the EC

The European Commission (EC) has approved Novartis' Votubia (everolimus) for the treatment of non-cancerous brain tumours associated with tuberous sclerosis complex (TSC). The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Votubia is an oral medication that is for patients aged 3 years and older. Prior to this treatment, brain surgery was the only treatment option for children and adults in the European Union with these tumours, known as subependymal giant cell astrocytoma (SEGA), associated with TSC.

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 (hydrocephalus). It is a genetic disorder that may cause SEGAs to form in the vital organs, most commonly affecting the brain and kidneys. It can cause life-threatening brain swelling in children and adults.

It works by targeting mTOR, a protein which is a regulator of tumour cell division, blood vessel growth and cell metabolism. Defects in genes cause mTOR's activity to increase, which can cause uncontrolled tumour cell growth. By stopping this increased activity, Votubia reduces these problems.

12th September 2011

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