UCB’s Fintepla oral seizure treatment receives FDA approval

28-Mar-2022 - Last updated on 28-Mar-2022 at 15:16 GMT

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The drug has received the agency’s seal of approval to treat seizures associated with difficult-to-treat seizures associated with Lennox-Gastaut syndrome.

Pharmaceutical firm UCB has announced that its Fintepla (fenfluramine) oral solution CIV has received approval from the US Food and Drug Administration (FDA) for treating seizures tied to Lennox-Gastaut syndrome (LGS) in patients two years of age and older.

The drug already has been approved for the treatment of seizures associated with Dravet syndrome (DS) in patients two years of age and older. Additionally, the FDA granted Fintepla pediatric exclusivity. Fintepla for LGS is available through a restricted distribution program, the Fintepla Risk Evaluation and Mitigation Strategy (REMS) Program. The drug was developed by Zogenix, a company recently acquired by UCB.

"LGS is a severe, life-long disease with wide-ranging effects beyond seizures. It impacts every aspect of daily life and puts great strain on the entire family. There is a desperate need for more effective treatment options," said Tracy Dixon-Salazar, executive director of the Lennox-Gastaut Syndrome Foundation and mother to an adult daughter with LGS. "The potential for Fintepla to make a difference in the daily, horrific seizures we are dealing with in LGS cannot be understated. We are so grateful for the researchers who have worked so hard to help all of us suffering at the hands of LGS."

"The approval of Fintepla for Lennox-Gastaut syndrome highlights our continued commitment to bringing differentiated medicines to patients who may not be well controlled on current therapies and their caregivers," said Mike Davis, head of global epilepsy with UCB. "We are proud to add Fintepla as a treatment for Dravet syndrome, and now Lennox-Gastaut syndrome, to our portfolio of epilepsy medicines to help reduce the impact and burden of seizures, including severe epilepsy syndromes that have high pediatric morbidity and mortality rates."

LGS is a severe childhood-onset developmental and epileptic encephalopathy (DEE) condition typified by drug-refractory seizures with high morbidity, in addition to serious impairment of neurodevelopmental, cognitive, and motor functions. LGS impacts an estimated 30,000 to 50,000 patients in the US.

The condition also has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioral challenges, and mobility. Sudden unexpected death in epilepsy (SUDEP) is a major concern for people living with LGS.

According to UCB, Fintepla demonstrated efficacy in the most difficult-to-treat seizure types, including drop seizures, which cause a person to suddenly lose muscle tone, become limp, and fall to the ground, with a high likelihood of injury. The treatment has a mechanism of action different from and complementary to current seizure medications, and it can be used with no disruptions to current antiseizure regimens.

In the global placebo-controlled Phase III clinical study, there reportedly were numerically greater improvements on the Clinical Global Impressions scale (CG-I) in patients living with LGS when taking Fintepla.

The FDA approval was supported by safety and efficacy data from a global, randomized, placebo-controlled Phase III clinical trial in 263 patients with LGS (age 2-35 years), which demonstrated that Fintepla at a dose of 0.7 mg/kg/day significantly reduced monthly drop seizures frequency by a median of 23.7% from baseline compared to 8.7% placebo (p=0.0037). Nearly a fourth of those patients on Fintepla 0.7 mg/kg/day experienced a ≥50% reduction in drop seizure frequency per 28 days; 18% with ≥50% to <75% reduction and 6% ≥75% reduction.

According to researchers, the common adverse reactions that occurred in patients treated with Fintepla (incidence at least 10% and greater than placebo) were diarrhea, decreased appetite, fatigue, somnolence, and vomiting. The Fintepla safety database includes long-term cardiovascular safety data for patients treated for up to three years in DS and LGS.

"LGS is one of the most challenging epileptic encephalopathies to treat, and the vast majority of patients are not well controlled, despite a regimen of multiple antiepileptic drugs," said Kelly Knupp, associate professor at Children's Hospital Colorado. "As a complementary therapy, Fintepla offers a different mechanism of action and demonstrated ability to significantly reduce the number of seizures associated with a drop, a critical measure for managing this severe form of epilepsy."

UCB reports the company is committed to supporting patient access to Fintepla, and as part of that commitment, its Zogenix Central comprehensive support program will provide ongoing product assistance to patients, caregivers, and their medical teams.