Antiepileptic drugs company UCB reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) for BRIVIACT (brivaracetam) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy.

Following the US FDA approach to assessing extrapolated data, the company was able to support its BRIVIACT monotherapy submission with a wealth of brivaracetam clinical trials data, which involved more than 2,400 adult patients with POS. BRIVIACT is available in three formulations (film-coated tablets, oral solution and injection).

With this US FDA approval, the adults and adolescents aged 16 years and older with POS in the US can now be initiated on BRIVIACT as monotherapy or adjunctive therapy. This new indication comes 18 months after launch of BRIVIACT in the US, is an adjunctive treatment in patients in this age group, according to the company.

In the US, BRIVIACT is approved as monotherapy and adjunctive therapy (a therapy used together with primary treatment) for the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy,stated the company.

BRIVIACT is the newest antiepileptic drug (AED) in the 'racetam' class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment for monotherapy or adjunctive therapy, added the company.

Epilepsy is a chronic neurological disorder of the brain. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. Around one-third of patients with epilepsy currently live with uncontrolled seizures.