FDA Expands Approval for UCB’s Fintepla in Lennox-Gastaut Syndrome Associated Seizures

The FDA has approved UCB’s Fintepla (flenfuramine) for patients two years and older experiencing seizures associated with Lennox-Gastaut syndrome.

The serotonin releasing agent was previously been approved by the agency in June 2020 for patients with seizures associated with Dravet syndrome.

The expanded FDA approval was supported by positive results from a phase 3 clinical trial in 263 patients between the ages of two and 35. Those treated with Fintepla showed a 23.7 percent mean reduction in monthly seizures, compared with 8.7 percent for those given placebo.

Belgium-based UCB acquired Fintepla as part of its purchase of Zogenix earlier this month for approximately $1.9 billion.