Neurology

    Kigabeq®

    Vigabatrin scored soluble tablets, 100 mg & 500 mg

    Kigabeq® is a pediatric form of vigabatrin (soluble tablets).

    Pharmaceutical form

    Kigabeq® is a pediatric form of vigabatrin developed as breakable soluble tablets with two strengths (500mg and 100mg).(1, 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(3).

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

    Distribution

    France and United Kingdom:
    Laboratoire Biocodex, Gentilly, France

    Baltic countries:
    UAB ENTAFARMA, Širvintai dist. munic., Lituania

    References

    1. Summary of Product Characteristics (SmPC) KIGABEQ
    2. Human medicine European public assessment report (EPAR)
    3. Inventory of paediatric therapeutic needs: Neurology (EMA/562919/2013)

    Undisclosed Project

    New orphan drug to treat a severe and rare, paediatric encephalopathic epilepsy

    Pharmaceutical form

    Develop a specific paediatric controlled-release of this drug to address all patients from the age of 1 year.