MHRA Extends Label of UCB’s Briviact in Patients Between Two and Four Years Old

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has extended the indications for UCB’s Briviact (brivaracetam) to include patients with partial-onset seizures who are between two and four years old.

The drug was first approved in the UK in 2016 as an add-on treatment for partial-onset seizures, with or without secondary generalized seizures, in adults with epilepsy.

The MHRA decision follows a recommendation by the EU’s Committee for Medicinal Products for Human Use (CHMP) in January 2022 for a label extension for the same pediatric population.

Briviact, which was initially approved by the FDA in 2016 as an add-on treatment for adults, is now FDA-approved to treat patients one month or older with partial-onset seizures.