Orphelia Pharma secures European patent covering KIGABEQ®, the first pediatric formulation of vigabatrin

Company benefits from protection period until 2036

Paris and Lyon, France, April 18th, 2024 – Orphelia Pharma, a pharmaceutical company dedicated to the development and marketing of pediatric and orphan medicines, today announces that the European Patent Office (EPO) has issued an intention to grant patent number EP3426230 for KIGABEQ®.

This European patent and its granted US counterpart (US 10,813,898), entitled “Solid dosage forms of vigabatrin”, are solely owned by Orphelia Pharma. Based on the filing date of the priority PCT application, the patent protection is expected to last until 2036.

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 has been granted a Paediatric Use Marketing Authorization (PUMA) in Europe.

“Following the issuance of the US patent, the grant of the EU patent highlights the innovative nature of KIGABEQ® formulation” said Hugues Bienaymé, General Manager of Orphelia Pharma. “This patent underscores our dedication to innovation which lies at the heart of our development strategy towards better pediatric medicines.”


KIGABEQ® is the first pediatric formulation of vigabatrin, an essential anti-epileptic drug. Presented as soluble and scored tablets of 100 mg and 500 mg for oral or (naso)gastric administration, KIGABEQ® is notably indicated for the treatment of infantile spasms (West syndrome), an extremely serious epileptic encephalopathy of the infant. KIGABEQ® was developed exclusively for children and has been granted European Pediatric Marketing Authorization (PUMA).

For further information: https://www.ema.europa.eu/en/medicines/human/EPAR/kigabeq

About infantile spasms

West syndrome, or infantile spasms, is an extremely serious epileptic encephalopathy in infants that combines epileptic spasms, psychomotor deterioration and a hypsarrhythmic type electroencephalogram. It is a rare disease, with an estimated incidence of 5 per 10,000 births. It can occur in an infant with previously normal development or with pre-existing mental retardation; in all cases, infantile spasms severely hamper the psychomotor development. Pharmacological treatment should be started quickly to allow the spasms to stop and improve the prognosis.

For further information: https://www.orpha.net/fr/disease/detail/3451

About Orphelia Pharma

Orphelia Pharma is a pharmaceutical company based in Paris and Lyon that develops and markets medicines for the treatment of pediatric and orphan diseases. The company’s mission is to provide patients with essential products in the fields of neurology and oncology, in formulations adapted to the pediatric population. Orphelia Pharma conducts research projects through academic and industrial partnerships. It has recently established regional agreements in European territories and is expanding its footprint across the world.

For further information: www.orphelia-pharma.eu, LinkedIn