Ucb, a Belgian biopharmaceutical company, presented new data on the progress of oral fenfluramine solution and its broader portfolio related to epilepsy at the 35th International Epilepsy Congress (Iec) held in Dublin from September 2nd to 6th. Along with 9 abstracts, including a late-breaker, 2 oral presentations focused on various forms of epilepsy, as well as rare epileptic conditions such as Dravet syndrome (Ds), Lennox-Gastaut syndrome (Lgs), and CDKL5 deficiency disorder (cyclin-dependent kinase-like 5).
Mike Davis, Head of Global Epilepsy & Rare Syndromes at Ucb, stated that they continuously challenge the status quo to do more for people living with different types of epileptic seizures and rare syndromes. They aim to make a positive impact through innovative research, leveraging their expertise and competence in areas where they have a significant history and skill set, as well as in new therapeutic areas such as Dravet and Lennox-Gastaut syndromes. The data presented at Iec highlight their commitment to improving the lives of patients and families.
Ucb conducted a review of published studies where patients were treated with fenfluramine to manage seizures, including generalized tonic-clonic seizures (Gtcs) or tonic-clonic seizures (Tcs), in various types of developmental and epileptic encephalopathies (Dee) or rare epileptic conditions. The review included data from 13 studies, including randomized controlled trials, observational studies, open studies, and case series, involving a total of 561 patients (360 with Dravet syndrome and 176 with Lennox-Gastaut syndrome). Not all patients in these studies experienced Gtcs or Tcs. Eight trials reported a reduction of ≥75% and/or 100% in Gtcs or Tcs, with 70% and 55% of patients experiencing a reduction of ≥75% and 100% respectively. Five studies showed that more than half of the patients were seizure-free after treatment with fenfluramine.
Helen Cross, the lead author and holder of the Prince of Wales’s Chair of Childhood Epilepsy, commented that these data demonstrated high levels of Gtcs control, setting new standards for what can be achieved in Dravet syndrome and providing insights for the treatment of other epileptic encephalopathies. Gtcs are a major concern due to the risk of sudden unexpected death in epilepsy (Sudep).
Orrin Devinsky, director of the Comprehensive Epilepsy Center at Nyu Langone Health, emphasized the wide-ranging impact of Dravet and Lennox-Gastaut syndromes, with emotional and objective consequences for parents, relatives, and loved ones. The data presented at Iec show that it is possible to achieve more ambitious goals in improving care for children and adults living with these difficult-to-treat conditions.
The latest data presented at Iec provided further evidence of the safety profile and efficacy of fenfluramine in adults with Dravet syndrome.
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