UCB announced that it will move forward with regulatory submissions for Fintepla® (fenfluramine) as a treatment for seizures associated with CDKL5 Deficiency Disorder (CDD), following highly positive results from its Phase 3 clinical trial. This represents a potential third indication for Fintepla, which is already approved for Dravet syndrome and Lennox-Gastaut syndrome.
The randomized, placebo-controlled trial evaluated 87 patients aged 1 to 35 with CDD, a rare and severe developmental and epileptic encephalopathy. Fintepla achieved its primary endpoint, delivering a statistically significant 47.6% median reduction in monthly countable motor seizures compared to a 2.8% reduction with placebo. Nearly 45% of patients receiving Fintepla experienced a 50% or greater reduction in seizures, versus just 4.5% in the control group.
Investigators also reported meaningful global improvements, with 38% of treated patients rated “much improved” or “very much improved,” compared with 7% on placebo. Caregiver assessments indicated even greater perceived benefit. Additionally, patients receiving Fintepla gained a median of 6.4 additional seizure-free days per month.
Given these compelling results, UCB plans to file for approval “as soon as possible,” marking an important potential advancement for patients and families impacted by CDD.
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