VOTUBIA (everolimus), tyrosine kinase protein inhibitor
RARE DISEASE - New indication
Opinions on drugs - Posted on Sep 12 2018
Reason for request
Extension of indication
High clinical benefit and minor clinical improvement in the treatment of drug-resistant, partial epileptic seizures, with or without secondary generalisation, associated with Bourneville tuberous sclerosis.
- VOTUBIA has MA in combination in patients (>2 years) with drug-resistant partial epileptic seizures, with or without secondary generalisation, associated with Bourneville tuberous sclerosis (BTS).
VOTUBIA was superior to the placebo on the reduction in the frequency of epileptic seizures at 3 months in patients with BTS and partial epilepsy resistant to a combination of 2 or 3 antiepileptic drugs. The effect appeared to be sustained after 1 year’s treatment.
The most common adverse effects include stomatitis, mouth ulcers, diarrhoea, with uncertainty as to the long-term safety in a young population.
Clinical Added Value