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.
About FINTEPLA® (fenfluramine)
FINTEPLA® (fenfluramine) oral solution is a prescription medication approved by the FDA and EMA, and under regulatory review with PMDA (Japan), for the treatment of seizures associated with Dravet syndrome in patients two years of age and older.A Type II Variation Application for treatment of seizures associated with LGS has also been submitted to the European Medicines Agency (EMA).
In the United States, FINTEPLA is available only through a restricted distribution program called the FINTEPLA REMS program. FINTEPLA is available in Europe under a controlled access program requested by the EMA to prevent off-label use for weight management and to confirm that prescribing physicians have been informed of the need for periodic cardiac monitoring in patients taking FINTEPLA.
March 29, 2022
