Swiss Approves Novartis’ Votubia Tablets for SEGA
The drug is the first to be approved in Switzerland for treating subependymal giant cell astrocytoma (SEGA).
The Swiss regulatory authorities approved Novartis’ Votubia? (everolimus) tablets for treating subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) in patients aged three years and over who are not suitable for surgery.
The drug is the first to be approved in Switzerland for this indication. In the U.S. everolimus is marketed as Afinitor? for the SEGA indication. An equivalent regulatory review is in progress in the EU.
Clearance of Votubia for the treatment of SEGA by the Swiss authorities was based on a prospective, open-label Phase II study in 28 patients, which showed that treatment with Votubia led to 75% of participants experiencing at least a 30% reduction in the size of their largest SEGA. Thirty-two percent of patients expe
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