Novartis granted EU approval for Votubia

Novartis has been granted approval by the European Commission for its groundbreaking new tuberous sclerosis complex therapy Votubia.

The everolimus-based treatment has been ratified as a means of addressing subependymal giant cell astrocytoma (SEGA) associated with the condition among patients aged three years and older that are not able to receive surgery.

Approval was based on positive findings from a phase II clinical trial programme, in which the safety and efficacy of the drug was demonstrated, leading to a recommendation from the Committee for Medicinal Products for Human Use.

Votubia now becomes the first drug-based therapy to be authorised for this patient group, with brain surgery having previously been the only treatment option for those affected.

Herve Hoppenot, president of Novartis Oncology, said: "The approval of Votubia in the European Union means that for the first time, patients living with SEGA associated with tuberous sclerosis complex will have an effective therapeutic option."

This comes after Afinitor, another everolimus-based therapy from Novartis, was approved in Europe as a pancreatic neuroendocrine tumour treatment earlier this month.