Data from Pharmawand - Curated by EPG Health - Date added 15 May 2018
The FDA has approved a supplemental new drug application (sNDA) for the company's newest anti-epileptic drug (AED) Briviact (brivaracetam) CV oral formulations, from UCB, indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older. This approval provides clinicians with the convenient option to prescribe Briviact to their pediatric patients as a tablet or oral solution, providing flexible administration options which are important considerations when treating children. As the safety of Briviact injection has not been established in pediatric patients, Briviact injection is indicated for the treatment of partial-onset seizures only in patients 16 years of age and older. As a result of the FDA's decision, children age four years and older with partial-onset seizures in the U.S. can now be treated with Briviact. This extends the clinical application for Briviact which already has a similar indication for adults.
The expanded FDA indication for Briviact is based on the principle of extrapolation of its efficacy data from adults to children, and is supported by safety and pharmacokinetics data collected in children. Adverse reactions in pediatric patients are generally similar to those seen in adult patients. This principle of extrapolating clinical data from well controlled studies in adults has been recognized by the FDA as potentially addressing the challenge of limited pediatric data availability.
The safety and effectiveness of Briviact in the treatment of partial-onset seizures have been established in patients four years of age and older. Use of Briviact in these age groups is supported by evidence from placebo-controlled partial-onset seizure studies of Briviact in adults with additional pharmacokinetic and open-label safety studies in pediatric patients age 4 to younger than 16 years of age. Partial-onset seizures in pediatric patients aged 4 to 16 years of age are similar to those in adults and a similar AED exposure-response relationship has been demonstrated. Weight-based dose adaptations have been established in the pediatric population to achieve similar plasma concentrations as observed in adults. The safety and tolerability profile for Briviact in pediatric patients 4 to 16 years of age is generally similar to that seen with adult patients.