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The European Commission has granted Kigabeq paediatric use marketing authorisation (PUMA) following the recommendation of the Committee for Medicinal Products for Human Use (CHMP).
Kigabeq is meant for the treatment of infantile spasms, or West’s syndrome, which is an uncommon and severe form of epilepsy associated with a highly-resistant seizure type and a rapid psychomotor regression. It can also be used to treat partial epilepsy in infants and children from one month to seven years of age.
Vigabatrin is the active substance in Kigabeq, which is an antiepileptic drug that has been marketed in Europe since 1989 and is commonly used to treat adults and paediatric patients. However, it was only available in the European Union as 500mg film-coated tablets or granules for oral solution sachets that need to be split or diluted to make them appropriate for children.
The CHMP recommended a PUMA for a child-friendly formulation in July, so it would be easier to administer and reduce the risk of medication errors.
The new formulation has been developed especially for young children and will be available as 100mg tablets.
Gilles Alberici, president of Orphelia Pharma, who developed the new formulation, said: “This marketing authorisation comes at the right time for Orphelia Pharma and the company will now structure itself upon this first medicine in which we have great expectations.
“Our vision is to develop and bring new paediatric drugs with age-adapted formulations to the market for the treatment of life-threatening orphan indications.”
Orphelia Pharma also worked alongside consultants at PharmaLex to apply for the PUMA.
Dr Laura Boteanu-Jotzu, director and head of regulatory affairs team, PharmaLex, said: “This was a challenging project and its success is a result of the high motivation and effort from every member of the intercompany team.”
Dr Thomas Dobmeyer, chief executive of PharmaLex, said: “The trusted partnership between Orphelia Pharma and PharmaLex, alongside the shared willingness to reach the objective of Kigabeq resulted in the granting of this PUMA.”