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UCB’s Epilepsy Drug Briviact (brivaracetam) Gains Approval in Japan for Focal Onset Seizures | 2024 | iPharmaCenter

Briviact (brivaracetam) has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) as both a monotherapy and adjunctive treatment for adults with epilepsy experiencing partial-onset seizures, with or without secondary generalization. This approval introduces a new treatment option for epilepsy patients in Japan.

The approval is supported by a successful Phase 3 clinical trial, which demonstrated the efficacy and safety of brivaracetam as an add-on therapy for patients with focal-onset seizures across the Asia-Pacific region. This study included 449 participants aged 16 to 80, with 97 of them being from Japan.

Briviact's addition to the treatment arsenal in Japan follows its approval in other parts of the Asia-Pacific region. It is already authorized in Taiwan as both monotherapy and adjunctive therapy for focal-onset seizures in patients aged four years and older. Additionally, it has received approval in Hong Kong and the Republic of Korea as an adjunctive therapy for patients aged 16 and older, although it has not yet been launched in Korea.

Epilepsy is a chronic neurological condition affecting approximately 710,000 to 930,000 individuals in Japan. Despite available treatments, many patients continue to experience seizures.

The Phase 3 study, which led to this approval, was a randomized, double-blind, placebo-controlled trial involving participants with focal-onset seizures.

Brivaracetam significantly reduced seizure frequency compared to placebo, with a 24.5% reduction for the 50 mg/day dose and a 33.4% reduction for the 200 mg/day dose. Additionally, the proportion of patients achieving a 50% responder rate was significantly higher in the brivaracetam groups compared to placebo.

Brivaracetam was generally well tolerated, with similar rates of treatment-emergent adverse events (TEAEs) between the brivaracetam and placebo groups. Common TEAEs included somnolence and dizziness, but the incidence was not significantly higher than in the placebo group. The safety and efficacy profiles of brivaracetam in this study were consistent with those observed in predominantly non-Asian populations.

The introduction of Briviact in Japan is expected to provide a significant benefit to patients and healthcare providers by offering an effective and well-tolerated treatment option for managing focal-onset seizures in adults with epilepsy.


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