The US Food and Drug Administration has issued a green-light for UCB’s novel epilepsy drug Briviact, offering patients aged 16 years and over a new therapeutic option for treating partial-onset seizures.
According to UCB, around 30% of people with epilepsy remain uncontrolled despite currently available therapies, leaving them at higher risk of seizures that can have devastating physical and emotional consequences.
The firm is hoping that Briviact (brivaracetam) will go some way in helping to address this unmet need, given that clinical trials have shown its efficacy (over placebo) in reducing partial-onset seizure frequency during the treatment period.
According to pooled data from three pivotal Phase III studies (N01252, N01253 and N01358), Briviact cut seizure frequency per 28 days by 19.5%, 24.4% and 24.0% at 50mg/day, 100mg/day and 200 mg/day doses, respectively.
Also, the proportion of patients showing a 50% or greater reduction in partial-onset seizure frequency was 34.2% (50 mg/day), 39.5% (100 mg/day) and 37.8% (200 mg/day) versus 20.3% for placebo.
On the safety side, trials showed that Briviact was generally well tolerated by patients, with the most commonly reported adverse reactions with the drug somnolence (15.2%), dizziness (11.2%), headache (9.6%) and fatigue (8.7%).
The US Drug Enforcement Administration is anticipated to classify Briviact according to the drug scheduling process within the next 90 days, after which time it will become commercially available in the US, UCB noted.
Briviact was also approved in Europe earlier this year, and is already available to patients in the UK and Germany.