Swissmedic has announced that it has approved Votubia (everolimus) tablets for the treatment of subependymal giant cell astrocytoma associated with tuberous sclerosis in patients aged three years and older.
Everolimus targets the mTOR protein to reduce cell proliferation, blood vessel growth and glucose uptake related to subependymal giant cell astrocytoma associated with tuberous sclerosis.
The open-label, single-arm Phase II study enrolled 28 patients and showed that patients experienced a reduction in the size of their largest subependymal giant cell astrocytoma and improvement in facial angiofibromas.
Novartis Oncology president Hervé Hoppenot said that the approval of Votubia was the first in Europe, and that it emphasised their commitment to help patients worldwide to improve their management of the difficult-to-treat disease.
The common adverse events reported from tablet use were mouth sores, upper respiratory tract infections, sinusitis, middle ear infections and fever.