Novartis receives CHMP backing for Votubia

Novartis has been granted a Committee for Medicinal Products for Human Use (CHMP) recommendation for approval of its new tuberous sclerosis complex treatment Votubia.

The innovative therapy has been endorsed by the European Medicines Agency committee based on positive data from clinical trials, in which it demonstrated efficacy in combating subependymal giant cell astrocytoma (SEGA).

Votubia is being positioned as a tablet-based treatment for tuberous sclerosis patients affected by SEGA who are not amenable to surgery, with US regulators having already ratified the drug under the name Afinitor.

Should the European Commission follow suit, it would become the first therapy option made available to European patients with this condition.

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 presented data from a pair of phase III trials showcasing the efficacy of the developmental drug ACZ885 against severe gouty arthritis.