FDA Approves Seizure Drug for Infants

The FDA has approved an expanded indication for UCB’s Briviact (brivaracetam) CV tablets, oral solution, and injection to treat partial-onset seizures in patients as young as one month of age. This is the first time that the IV formulation will be available for pediatric patients when oral administration is temporarily not feasible and is the only IV formulation FDA-approved to treat partial-onset seizures in children one month of age and older in nearly seven years.

Tablets, oral solution, and IV dosage forms are now FDA-approved as both monotherapy or adjunctive therapy for the treatment of partial-onset seizures in patients one month of age and older.

Data in pediatric patients includes long-term retention rates over two years. In an open label follow-up pediatric study, an estimated 71.4% and 64.3% of patients, aged 1 month < 17 years with partial-onset seizures, remained on treatment at year and two years, respectively.

Raman Sankar, M.D., Ph.D.

“We often see children with seizures hospitalized, so it’s important to have a therapy like this that can offer rapid administration in an effective dose when needed and does not require titration. The availability of the oral dose forms also allows continuity of treatment when these young patients are transitioning from hospital to home,” Raman Sankar, M.D., Ph.D., distinguished professor and chief of pediatric neurology at the Rubin Brown Endowed Chair for the David Geffen School of Medicine at UCLA and UCLA Mattel Children’s Hospital, said in a statement.

In 2015, 1.2% of the U.S. population had active epilepsy. This is about 3.4 million people with epilepsy nationwide: 3 million adults and 470,000 children, according to the Centers for Disease Control.

In the pediatric trials, the safety profile was found to be similar to that of adults. In adult trials, Briviact was shown to cause psychiatric adverse reactions, including non-psychotic and psychotic symptoms. These events were reported in about 13% of adult patients taking at least 50 mg per day of Briviact compared with 8% of adult patients taking placebo. A total of 1.7% of adult patients taking the therapy discontinued treatment due to psychiatric reactions compared with 1.3% of patients taking placebo.

Briviact was approved in the United States in 2016 as an add-on therapy for adult patients. It was approved as monotherapy for adults in September 2017, and as monotherapy or adjunctive therapy in patients four years of age and older with partial-onset seizures in 2018. Briviact is available in three formulations: oral tablets, oral solution, and intravenous injection.