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US FDA approves expanded indication for UCB’s Briviact to treat paediatric patients

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The US Food and Drug Administration (FDA) has approved an expanded indication for UCB’s Briviact (brivaracetam) CV as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in paediatric patients aged one month and above.

The US Food and Drug Administration (FDA) has approved an expanded indication for UCB’s Briviact (brivaracetam) CV as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in paediatric patients aged one month and above.

In 2016, the drug was approved in the US as an add-on therapy for adult patients and was also approved as monotherapy for adults in September 2017.

Briviact was approved as monotherapy or adjunctive therapy to treat partial-onset seizures in patients aged four years and above in 2018.

It is available in three formulations including oral tablets, oral solution, and intravenous (IV) injection.

UCB claimed that it is the only IV formulation FDA-approved for the treatment of partial-onset seizures for children in nearly seven years.

UCLA Mattel Children’s Hospital and UCLA David Geffen School of Medicine Rubin Brown Endowed Chair Pediatric Neurology chief and distinguished professor Raman Sankar said: “We often see children with seizures hospitalized, so it’s important to have a therapy like BRIVIACT IV 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.

“Now that Briviact IV and oral formulations are an approved therapy for partial-onset seizures in children as young as one month, we have a new option that helps meet a critical need in pediatric epilepsy.”

It was found that around 71.4% and 64.3% of patients aged one month and above 17 years with partial-onset seizures remained on treatment with Briviact for one and two years in open-label paediatric trials.

The most common adverse reactions found in patients using Briviact include somnolence and sedation, dizziness, fatigue, nausea and vomiting symptoms.

This is not a CAPTIS article. Originally, it was published here.