Novartis’ Votubia (everolimus) has been granted a positive opinion by the CHMP for patients aged three or above with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC).
The Committee’s decision is based on a Phase II study which showed that 78% of patients experienced a reduction of 30% or more in the size of their largest SEGA and a third saw a reduction of more than 50% at six months.
Hervé Hoppenot, President of Novartis Oncology, says the positive opinion is “encouraging” news for patients.
Votubia would become the first medication available for relevant patients in the European Union (EU).
SEGAs, or benign brain tumours, occur in up a fifth of patients with TSC. The condition is a genetic disorder which affects between one to two million people worldwide. In Europe, there are an estimated nine cases per 100,000 people.
The CHMP’s recommendation has now been passed on to the European Commission. A final decision is expected within the next three months.
“Our focus on tuberous sclerosis complex research reflects the commitment Novartis has made to develop innovative therapies to help address unmet medical needs,” said. Hervé Hoppenot.