Vigabatrin (2) – Kigabeq®

Children aged from 1 month to under 7 years who suffer from infantile spasms (West syndrome)

• As the necessary evidence has not been submitted, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
• No dossier was submitted by the pharmaceutical manufacturer at the relevant time.
• Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment is made as to whether, or to what extent, the active ingredient (INN) vigabatrin offers added benefit compared with the appropriate comparator therapy in the therapeutic indication ‘children aged from 1 month to under 7 years suffering from infantile spasms (West syndrome)’, there is additional benefit compared with the appropriate comparator therapy.
• Appropriate comparator therapy
  • The appropriate comparator therapy was defined as follows: children aged from 1 month to under 7 years who suffer from infantile spasms (West syndrome)
  • Appropriate comparator therapy: tetracosactide or glucocorticoids (prednisone, prednisolone)

Courtesy translation only, please refer to the German original.