Votubia tablets are indicated as a treatment for children and adults suffering from subependymal giant cell astrocytoma (SEGA) or brain tumors linked with tuberous sclerosis complex (TSC).
The CHMP’s decision was based on positive results from an open-label, prospective and single-arm study in which 78% of patients experienced a reduction of 30% or greater in the size of their largest SEGA and 33% experienced a reduction of 50% or greater at six months relative to baseline.
Novartis Oncology president Herve Hoppenot said the positive CHMP opinion for Votubia is encouraging as it may lead to the approval of the first medication in the European Union for patients with this challenging disease.
"Our focus on tuberous sclerosis complex research reflects the commitment Novartis has made to develop therapies to help address unmet medical needs," Hoppenot said.