BASEL (dpa-AFX) - Swiss drug maker Novartis AG (NVS) Thursday said that the European Commission or EC approved Votubia tablets for the treatment of patients aged 3 years and older, with subependymal giant cell astrocytoma or SEGA associated with tuberous sclerosis complex or TSC, who require therapeutic intervention but are not amenable to surgery.
Votubia is the first medication to treat children and adults with SEGA associated with TSC. SEGA is a non-cancerous brain tumor that can cause life-threatening brain swelling in children and adults with TSC.
Prior to the approval of Votubia, an oral medication, brain surgery was the only treatment option for children and adults in the European Union with SEGA associated with TSC.
The company said the EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use in June and is based on a prospective, open-label, single-arm, Phase II study of 28 patients showing SEGA tumor reduction.
Hervé Hoppenot, President, Novartis Oncology said, 'The approval of Votubia in the European Union means that for the first time, patients living with SEGA associated with tuberous sclerosis complex will have an effective therapeutic option. This milestone serves as another example of the potential of mTOR inhibition with everolimus and we remain steadfast in our commitment to studying other manifestations of TSC.'
The company noted that an additional placebo-controlled phase III study examining this patient population was recently presented at the International TSC Research Conference in July. This trial met its primary endpoint of SEGA response rate.
Sergiusz Jozwiak, Professor, Department of Child Neurology, The Children's Memorial Health Institute, Warsaw, Poland, 'This approval is an important step forward in managing SEGAs associated with tuberous sclerosis complex, as surgery was previously the only available treatment option in the EU for these patients. As the first approved medication for this patient community, Votubia will help fill a critical unmet treatment need.'
NVS closed Wednesday's regular trading session at $57.04, up $1.10 or 1.97 percent.
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