Staff in regulatory affairs jobs at Novartis have been able to secure a recommendation for European approval of a new treatment for tuberous sclerosis complex.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive stance on ratifying Votubia for treating subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis.
This decision was reached based on positive data from a phase II clinical study, showing that patients unable to undergo surgery were able to benefit from a reduction in SEGA size using the drug.
If approved, Votubia would be the first treatment made available for this condition in the EU.
Herve Hoppenot, president of Novartis Oncology, said: "Our focus on tuberous sclerosis complex research reflects the commitment Novartis has made to develop innovative therapies to help address unmet medical needs."
Last month, the company's tablet therapy Afinitor became the first drug to be approved as a progressive pancreatic neuroendocrine tumour treatment in the US for nearly 30 years.