Paris and Lyon, August 28th, 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology, announces today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the issuance of a marketing authorization for the medicinal product Kigabeq® by the European Commission. As Kigabeq® has been exclusively developed for use in children, it should receive a Paediatric Use Marketing Authorization (PUMA).
Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug and will be available as scored soluble tablets of 100 mg and 500 mg strengths. Kigabeq® is expected to be used as first-line treatment for infantile spasms, an extremely severe early childhood encephalopathic epilepsy.
« We are particularly honoured with this decision which comes after several years of continuous efforts of ORPHELIA Pharma together with our academic partners », comments Hugues Bienaymé, Founder and General Manager of ORPHELIA Pharma. « This positive opinion is a key milestone in the process to make Kigabeq®, our first medicinal product, available to the pediatric community ».
« The CHMP has acknowledged the interest of Kigabeq® in improving health of epileptic children. We are eagerly awaiting the final marketing authorisation from the European Commission by October », highlights Gilles Alberici, Chairman of ORPHELIA Pharma. « Kigabeq® is expected to be the fourth human medicine to be granted a PUMA in Europe ».
About infantile spasms
Infantile spasms, or West Syndrome, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor delay and an hypsarythmic electroencephalogram. It is a rare disease with an estimated incidence of around 0.05 per 10,000. It affects infants who were previously normal or children with impaired cognitive development. Children with infantile spasms must be treated rapidly for spasms cessation and to improve prognosis.
About ORPHELIA Pharma
Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.