Briviact(brivaracetam)
Neurology· 1033 cited findings· 2 source documents
Company: UCB SA →
What the regulatory reviews say
Briviact (brivaracetam), also known as Nubriveo in Italy, is indicated as an adjunctive therapy for the treatment of partial-onset seizures, with or without secondary generalization, in patients aged 16 years and older with epilepsy. It was qualified as a new active substance and received a CHMP positive opinion between November 16-19, 2015, following an application submission on November 20, 2014.
Clinical trials demonstrated Briviact's efficacy in reducing partial-onset seizure (POS) frequency. A reduction in seizure frequency over placebo of 19.5% was observed. The median percentage reduction in POS frequency ranged from 17.03% to 32.45%. The 50% POS responder rate ranged from 20.0% to 36%, with odds ratios for this response ranging from 1.36 to 2.13. Seizure freedom rates ranged from 0% to 4%.
Regarding safety, common adverse events included dizziness (11.0% in the Briviact overall group vs. 7.2% in the placebo group), headache (10.0% in the Briviact overall group vs. 10.2% in the placebo group), and insomnia (2.8% in the Briviact overall group vs. 1.5% in the placebo group). Irritability was reported in 2.9% of the Briviact overall group, and convulsion in 2.5% of the Briviact overall group compared to 1.5% in the placebo group.
Key figures — cited to the source page
| Reduction in seizure frequency over PBO | 19.5 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.79 |
| % reduction in POS frequency (median) | 32.45 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.72 |
| 50% POS responder rate | 36 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.72 |
| Seizure freedom rate | 4 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.72 |
| Dizziness in BRV Overall group (Pool S1) | 11.0 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.96 |
| Headache in BRV Overall group (Pool S1) | 10.0 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.96 |
| New Active Substance Status | qualified as a new active substance | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.121 |
| CHMP positive opinion date | 16-19 November 2015 | UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR public asses, p.8 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.