Kigabeq®

Vigabatrin scored soluble tablets, 100 mg & 500 mg

West Syndrome (infantile spasms)

Kigabeq® is a pediatric form of vigabatrin (soluble tablets) for the first-line treatment of West syndrome, and in combination with other drugs, for resistant partial epilepsy (focal onset seizures).

West syndrome is a rare disorder characterized by the association of clusters of axial spasms, psychomotor retardation and an hypsarrhythmic interictal EEG pattern. It is the most frequent type of epileptic encephalopathy. It may occur in healthy infants and in those with abnormal cognitive development.⁽¹⁾

Pharmaceutical form

Kigabeq® is a pediatric form of vigabatrin developed as breakable soluble tablets with two strengths (500mg and 100mg).^(2,3)

Indications

Kigabeq® is approved in infants and children from 1 month to less than 7 years of age, for:

Treatment in monotherapy of infantile spasms (West’s syndrome).
Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalization, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated ⁽²⁾.

Unmet medical need in pediatric patients

In the “Revised priority list for studies into off-patent pediatric medicinal products” published in 2014, the EMA underlined the need of an “age-appropriate formulation” of vigabatrin. With its 2 strengths and the scored soluble tablets, Kigabeq® fully responds to this need⁽⁴⁾.

Kigabeq® was granted a paediatric-use marketing authorization (PUMA) in the European Union.

Distribution

France and Europe including United Kingdom:
Laboratoire Biocodex, Gentilly, France

Bibliography

Oussini M J Clin Pharmacol. 2019, Proposition of a Minimal Effective Dose of Vigabatrin for the Treatment of Infantile Spasms Using Pediatric and Adult Pharmacokinetic Data
Rodrigues Epilepsy Res. 2019, Pharmacokinetic evaluation of vigabatrin dose for the treatment of refractory focal seizures in children using adult and pediatric data.
SoluWest, un essai d’acceptabilité d’une nouvelle formulation pédiatrique de vigabatrine, Poster SFNP Soluwest V1 20180117-Vfinale

References