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 Benefit

Substantial

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Clinical Added Value

minor

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