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421052000

New Medicines

BriviactPartial onset seizures with or without secondary generalisation - adjunctive therapy in children from 2 to 4 years of age with epilepsy

Information

Briviact
Licence extension / variation
UCB Pharma
UCB Pharma

Development and Regulatory status

Launched
Launched
Launched
May 2022
May 22MHRA approves a licence change for Briviact to extend use to children aged 2 to 3 years (previously licensed from age of 4). The new indication is use as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy. The licence change applies to all formulations: 10mg, 25mg, 50mg, 75mg and 100mg tablets, 10mg/ml oral solution and 50mg in 5mL vial for injection/infusion [8].
Feb 22EMA approves licence change for Briviact [7].
Jan 22CHMP recommends a change to the indications for Briviact to permit use in children aged 2 years and older with epilepsy (previously only licensed from the age of 4). The proposed revised indication is “as adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy” [6].
Aug 21Approved in US to treat partial-onset seizures in patients ≥1 month [4].

Category

Binds to synaptic vesicle protein 2A (SV2A), a transmembrane glycoprotein found at presynaptic level in neurons and in endocrine cells. Oral solution.
Epilepsy is a common neurological disorder in childhood. Seizures and epilepsy affect infants and children more than any other age group. Epilepsy is about twice as common in children as in adults (about 700 per 100,000 in children under the age of 16 years compared to 330 per 100,000 in adults) [1].
Partial onset seizures with or without secondary generalisation - adjunctive therapy in children from 2 to 4 years of age with epilepsy
Intravenous and
Oral

Trial or other data

Nov 20PIII study (NCT01364597) continues to enrol; collection of primary outcome data should now be complete Jan 22 [3].
Apr 20PIII study (NCT01364597) is enrolling by invitation [2].
Aug 11PIII study to evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy starts (NCT01364597). 600 children aged up to 17 years will be recruited in countries including the US, EU & UK. Primary outcome is safety; secondary outcome is reduction from baseline to the end of the evaluation period for the number of seizure days. the study is due to complete Jun 21 [2].

Evidence based evaluations