October 10, 2022
UCB plans to release Briviact in Japan with an Asian study
UCB announced the Phase 3 study results of Briviact (brivaracetam), a placebo-controlled, parallel-group trial, to demonstrate the efficacy and safety of Briviact in patients with partial seizures with or without secondary generalization.
UCB announced its plans for regulatory submission in Japan based on the positive Phase 3 trial. The study recruited patients from Japan, Thailand, China, Philippines, Malaysia, Singapore, and Taiwan.
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UCB announced that it had met the primary endpoint, a reduction in 28-day partial-onset seizure (POS) versus placebo. Further, it announced that it had met all the secondary endpoints.
Briviact reduced partial-onset seizures by 24.6% versus placebo and 33.3% in patients on brivaracetam 200 mg/day.
41.1% of patients on 50mg/day and 49.3% of patients on 200mg/day achieved reduction a 50% reduction in POS, versus 19.0% of patients achieved on placebo.
The safety profile was consistent with existing studies.