Novartis has broadened the indications for its Votubia drug, the company said on Tuesday, when the European Union approved its use to treat refractory partial-onset seizures in patients with tuberous sclerosis complex.
Votubia is the first adjunctive treatment approved in the EU specifically for partial-onset seizures in children and adults with tuberous sclerosis complex, the Basel-based pharmaceuticals company said in a statement.
The decision marks the third TSC-related indication for Votubia in the EU, where it is also approved to treat subependymal giant cell astrocytoma and renal angiomyolipomas.
Tuberous sclerosis complex is a rare genetic disorder affecting up to one million people worldwide. Approximately 85 percent of individuals with TSC are affected by epilepsy, and uncontrolled seizures associated with TSC can be debilitating for patients.