[COLOR="#000000"]Novartis received approval from the European Commission (EC) for Votubia® (everolimus) tablets* for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. This marks the first approval of a medical treatment in this patient population in Europe.
“Renal angiomyolipomas affect the vast majority of patients with TSC and over time can cause debilitating symptoms, a decline in renal function, and possibly even the need for kidney transplant or dialysis,” said Dr. Chris Kingswood, Royal Sussex County Hospital, Brighton, United Kingdom. “This approval represents a major advance in the treatment of the disease in Europe, giving clinicians a non-surgical option to manage TSC kidney tumors.”[/color]