Date: 2017-09-15
Type of information: Granting of a Market Authorisation in the US
Product name: Briviact®
Compound: brivaracetam
Therapeutic area: CNS diseases - Neurological diseases
Action mechanism: antiepileptic agent. Brivaracetam is a novel high-affinity synaptic vesicle protein 2A (SV2A) ligand. Its anticonvulsant activity is believed to be mediated mainly through interference with a protein called synaptic vesicle protein 2A.
Company: UCB (Belgium)
Disease: partial-onset (focal) seizures in patients 16 years and older with epilepsy
Latest news:
- • On September 15, 2017, UCB announced that the FDA has approved a 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. This is a new indication for Briviact®, which is already approved in the U.S. as adjunctive treatment for partial-onset (focal) seizures in patients in this age group. As a result, adults and adolescents aged 16 years and older with POS in the U.S. can now be initiated on Briviact® as monotherapy or adjunctive therapy.
The most common adverse reactions (at least 5% for Briviact® and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
UCB submitted a supplemental application for a Briviact®monotherapy indication taking into account a recent General Advice Letter, issued by the FDA, which stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of POS to their use as monotherapy for the treatment of POS. As a result of the FDA’s approach to assessing extrapolated data, UCB 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.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2017-09-15
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
