Novartis' Votubia cleared as first drug in Switzerland for SEGA

Swissmedic, the Swiss drug regulation agency, has approved domestic drug major Novartis’ (NOVN: VX) Votubia (everolimus) tablets for the treatment of patients three years of age and older, with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), for whom surgery is not a suitable option.

Votubia, which is already approved for SEGA in the USA under the trade name Afinitor (The Pharma Letter November 1, 2010), is the first drug cleared in Switzerland to treat these patients, who are primarily children and adolescents.

"This approval of Votubia is significant for children and adults who have SEGA associated with tuberous sclerosis and, until now, have had limited treatment options," said Herve Hoppenot, president, Novartis Oncology, adding: "This milestone represents our first approval in Europe for Votubia and underscores our commitment to help patients worldwide improve their management of this difficult-to-treat disease."