ORPHELIA Pharma announces the commercial launch of Kigabeq® in France

Paris and Lyon, January 7th, 2020 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, announces today the preparation of Kigabeq® launch in France after having reached an agreement with the Comité Economique des Produits de Santé (CEPS).

Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug. Available as 100 mg and 500 mg scored soluble tablets for oral and (naso)gastric administration, Kigabeq® is indicated in the first-line treatment of infantile spasms, an extremely severe early childhood encephalopathic epilepsy. Kigabeq® has been developed exclusively for children aged  between 1 month and 6 years and was granted a Paediatric Use Marketing Authorization (PUMA).

« The price fixing in France highlights the clinical significance of Kigabeq® from the Haute Autorité de Santé (HAS) and CEPS perspectives, is the ultimate step prior to effective market launch in France », comments Hugues Bienaymé, general Manager of ORPHELIA Pharma. « We are working hard with our manufacturer and our wholesaler to make Kigabeq® available to neuropediatricians from April 2020 ».

« Vigabatrin is an essential component of the treatment of infantile spasms or West syndrome », adds Pr. Stéphane Auvin, neuropediatrician at Robert Debré hospital. « For this population of very young children, the accuracy of delivered dose and the ease of use allowed by Kigabeq® will facilitate therapeutic management ».

« The upcoming launch of Kigabeq® is the culmination of several years of research and efforts carried out in collaboration with ORPHELIA Pharma » concludes Dr. Catherine Chiron, neuropediatrician at Necker-Enfants-Malades Hospital and Research Director at Inserm. « We are particularly pleased that this collaboration now provides an optimized solution to our young patients ».

About infantile spasms

West Syndrome, or infantile spasms, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor retardation and an hypsarrhythmic electroencephalogram. It is a rare disease with an estimated incidence of around 5 per 10,000 living births. It affects infants whose development was normal or children with impaired cognitive development prior to spasms. Children with infantile spasms must be treated as soon as possible to stop spasms and improve prognosis.

About ORPHELIA Pharma

ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of rare and serious paediatric diseases. Our mission is to provide patients with essential hospital products in the fields of epilepsy and oncology with formulations adapted to the paediatric population. Our first product, Kigabeq®, obtained a Marketing Authorization in September 2018 and is being launched in Europe. Our second product, Ivozall®, was granted a European Marketing Authorization in November 2019. ORPHELIA Pharma also conducts research projects through academic and industrial collaborations.