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news.Novartis has received the European Commission (EC) approval for its Votubia (everolimus) tablets to treat subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC).
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Everolimus treats patients aged 3 years and older who require therapeutic intervention but are not amenable to surgery.
Everolimus targets mTOR, a protein that acts as a regulator of tumor cell division, blood vessel growth and cell metabolism.
The EC approval follows Committee for Medicinal Products for Human Use (CHMP) positive opinion based on a open-label, prospective, single-arm, Phase II study of 28 patients showing SEGA tumor reduction in patients with TSC.
An additional placebo-controlled phase III study examining the patient population met its primary endpoint of SEGA response rate.