The European Commission has approved Novartis’ Votubia (everolimus) for patients aged three and over with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC), who not amenable to surgery.
The approval is based on a Phase II study that revealed 78% of patients experienced a reduction of 30% of more in the size of largest SEGA, and a third saw a reduction of 50% after six months.
Hervé Hoppenot, President, Novartis Oncology, says patients will have for the first time “an effective therapeutic option”.
TSC affects approximately one to two million people worldwide and is associated with a variety of resulting disorders. In Europe, the prevalence in general population is estimated to be nearly nine cases per 100,000.
Prior to Votubia being approved, the only treatment for patients in the European Union with SEGA associated TSC was brain surgery.
Dr Sergiusz Jozwiak, Professor, Department of Child Neurology, The Children’s Memorial Health Institute, Warsaw, Poland, has welcomed its approval by the EC.
“This approval is an important step forward in managing SEGAs associated with tuberous sclerosis complex, as surgery was previously the only available treatment option in the EU for these patients,” he said. “As the first approved medication for this patient community, Votubia will help fill a critical unmet treatment need.”