The Food & Drug Administration (FDA) – the North-American regulatory authority -, extended the therapeutic indication of the BIAL medicine for epilepsy in the treatment of partial epileptic seizures in children from the age of 4 years.
This is FDA’s third approval to BIAL’s antiepileptic. The eslicarbazepine acetate was approved for the first time in 2013 in the USA, as a once-daily adjunctive treatment for patients with partial-onset (focal) seizures with or without secondary generalisation. In 2015, the FDA extended its indication as monotherapy in adults and now the regulatory authority approved eslicarbazepine acetate for the treatment of partial-onset seizures in children.
Epilepsy affects 3.4 million people in the United States of America, half a million are children and teenagers.
“This FDA decision is based on the results of several studies which demonstrate the safety and efficacy of our medicine in paediatrics. Last year, the European Commission gave the green light to our medicine to be used in all European Union countries in children and teenagers and now the FDA also extended its indication”, declares António Portela, CEO of BIAL Group. For us, this is one more milestone in our mission to reach more patients, developing an active and important role in the global economy. This is also the recognition of our team’s work, sustained on the scientific development and innovation”.