FDA Approves UCB’s Fintepla to Treat Seizures Associated with Lennox-Gastaut Syndrome
March 28, 2022
Rare Daily Staff
The U.S. Food and Drug Administration approved UCB’s Fintepla oral solution CIV for the treatment of seizures associated with Lennox-Gastaut syndrome in patients two years of age and older.
Lennox-Gastaut syndrome (LGS) is a severe childhood-onset developmental and epileptic encephalopathy (DEE) characterized by drug-refractory seizures with high morbidity as well as serious impairment of neurodevelopmental, cognitive, and motor functions and has far-reaching effects beyond seizures, including issues with communication, psychiatric symptoms, sleep, behavioral challenges, and mobility. Additionally, sudden unexpected death in epilepsy (SUDEP) is a major concern for people living with LGS. LGS affects an estimated 30,000 – 50,000 patients in the United States.
Fintepla (fenfluramine) was developed by Zogenix, which UCB acquired in March 2022. It is already 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 only through a restricted distribution program, called the Fintepla Risk Evaluation and Mitigation Strategy (REMS) Program.
Fintepla has 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. It 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 3 clinical study, there were numerically greater improvements on the Clinical Global Impressions scale (CG-I) in patients living with LGS when taking Fintepla.
“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, UCB.
The FDA approval was supported by safety and efficacy data from a global, randomized, placebo-controlled phase 3 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 percent from baseline compared to 8.7 percent placebo. Nearly a fourth of those patients on Fintepla 0.7 mg/kg/day experienced a ≥50 percent reduction in drop seizure frequency per 28 days; 18 percent with ≥50 percent to <75 percent reduction and 6 percent ≥75 percent reduction.
The common adverse reactions that occurred in patients treated with Fintepla (incidence at least 10 percent 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 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.”
Photo: Tracy Dixon Salazar, executive director of the Lennox-Gastaut Syndrome Foundation
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