November 5, 2012
Swiss-based drug manufacturer Novartis (NYSE: NVS ) announced today that it has received another green light from the European Commission for its tumor drug Votubia. The tablets can now be used to treat some adults with non-cancerous kidney tumors associated with tuberous sclerosis complex (TSC).
According to the company, this is the first drug approved in Europe for this indication. The only option for treating this sort of issue before had been surgery. The approval was based on a phase III study where 42% of patients taking the drug, also called everolimus, responded to the treatment, while 0% of the placebo group responded.
The ruling will allow Novartis to market the drug in the 27 member countries of the EU, as well as Iceland and Norway. Specifically, the drug has been approved in its tablet form, and is to be used for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex, or TSC, who don't need immediate surgery.
Votubia also has EU approval to treat a non-cancerous brain tumor associated with TSC.