Votubia was cleared as a combination therapy for patients aged two and up who experience refractory partial-onset seizures associated to tuberous sclerosis complex (TSC).
These kind of seizures are caused by growth of non-cancerous lesions in the brain in TSC, and affect up to 60% of patients the rare genetic disease.
Everolimus is a small molecule inhibitor of mTOR – the mammalian target of rapamycin which regulates cell division and metabolism – to prevent the tumors from forming.
The drug is already marketed by Novartis under the names Zortress (US) and Certican (EU) as an immunosuppressant for transplant surgery, and as Afinitor to treat general tumours.
Novartis claims Votubia is the only non-surgical treatment for TSC related seizures to be available in all 28 EU member states. It is also available in Iceland and Norway.
Increase in sales
Previously Novartis has told in-PharmaTechnologist it plans to expand the indication portfolio for Everolimus, after the firm said it had projected sales for the drug to take a hit with competition from Bristol-Myers Squibb’s Opdivo.
However, despite Novartis expecting a slow in sales for the biologic, total annual revenues for Everolimus in 2016 exceeded $390 million - up 19% compared to FY2015.
Votubia tablets and dispersible tablets are also indicated in the EU for the treatment of patients with subependymal giant cell astrocytoma (SEGA) linked to TSC.