MHLW (Japan) approves Briviact (brivaracetam) as monotherapy and adjunctive therapy in the treatment of partial onset seizures
UCB, announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing authorization for Briviact (brivaracetam) as monotherapy and adjunctive therapy in the treatment of partial onset seizures of epilepsy patients with or without secondary generalization in adult patients with epilepsy
Brivaracetam treatment is initiated without titration, meaning patients receive a therapeutic dose from the first day of treatment
This announcement marks the fourth approval for brivaracetam in the Asia-Pacific region, which is already approved in Taiwan as monotherapy and adjunctive therapy for focal-onset seizures in patients aged greater than 4 years and in Hong Kong and the Republic of Korea as adjunctive therapy for focal-onset seizures in patients aged greater than 16 years (BRV not launched in the Republic of Korea).
Epilepsy is a chronic neurological disorder affecting around 710,000–930,000 people in Japan. Despite currently available treatments, many patients with epilepsy still experience seizures regardless of using or having used at least one anti-seizure medication.
“There is an unmet need for epilepsy medicines that effectively and rapidly control seizures and are also well tolerated by patients,” said Konrad Werhahn, Global Head of Medical Affairs, Epilepsy & Rare Syndromes, UCB. "We remain committed to transforming epilepsy care, designing meaningful, patient-focused treatment outcomes for people impacted by epileptic seizures.”
The approval in Japan is based on clinical data from a Phase III, randomized, double-blind, placebo-controlled study of brivaracetam published in Epilepsia Open involving 449 patients aged greater than 16–80 years with epilepsy and focal-onset seizures in the Asia-Pacific region. The study included 97 Japanese patients, n=97 received greater than 1 dose of brivaracetam. The study met its primary endpoint as brivaracetam demonstrated statistically significant reductions over placebo in partial-onset seizure frequency per 28 days (percent reduction over placebo in 28-day adjusted focal seizure frequency was 24.5% and 33.4% with brivaracetam 50 mg/day and 200 mg/day, respectively, (P=0.0005 and p<0.0001). the proportion of patients showing a 50% responder rate was 19.0%, 41.1%, and 49.3% with placebo, brivaracetam 50?mg day, and brivaracetam 200?mg day, respectively (p><0.0001 for both brv groups vs. placebo), meaning the study met its secondary endpoint. brivaracetam was generally well tolerated by patients.
See-
Kwan P. et al. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebo-controlled, flexible-dose trial. Epilepsia, 2014. 55:38
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