The new epileptic drug brict ® will benefit at least 4 years old after being approved today

Source: Wuxi apptec, May 15, 2018, today, UCB, a biomedical company based in Belgium, announced that the U.S FDA has approved the company's latest application for supplementary new drugs (SNDA) of the antiepileptic drug breviact ® (brivaraceam, blexitan) oral preparation for the treatment of partial onset in patients aged 4 and over, either alone or as an adjuvant seizure，POS）。 Previously, the FDA approved briacat ® for use in POS alone or as an adjunct to patients 16 years and older Childhood epilepsy is the most common and serious nervous system disease among children and young people, affecting about 470000 children under the age of 18 in the United States, accounting for about a quarter of the global annual incidence Epilepsy in children is a complex disease that can have a significant impact on children's development and function Social problems and social stigma related to epilepsy are particularly cruel for children In the United States, the prevalence of childhood epilepsy has been rising steadily The Centers for Disease Control and Prevention (CDC) estimates that 0.6% of children aged 0-17 in the United States have active epilepsy, or about 6 epileptics per 1000 students Despite the increasing prevalence of epilepsy, about 10% to 20% of children with epilepsy can not be fully controlled after using the available antiepileptic drugs (AEDs) They are in urgent need of effective drugs to alleviate the disease and improve the quality of life Braviact ® brought by UCB is the latest antiepileptic drug in the family of synaptic vesicular protein 2A (SV2A), which is expected to bring therapeutic changes to this patient population Briiact ® shows a highly selective affinity for SV2A in the brain and can be absorbed rapidly and completely, which may contribute to its anticonvulsant effect When starting to use briiact ® as a monotherapy or adjuvant therapy, there is no need to gradually increase the dose, which allows doctors to treat with the treatment dose from the beginning The approval of SNDA is based on the principle of extrapolating efficacy data from adults to children, supported by safety and pharmacokinetic data collected from children Adverse reactions in children are usually similar to those in adults This principle of extrapolating clinical data from mature, well controlled studies has been approved by FDA as it may address the challenge of limited availability of pediatric data The safety and efficacy of briliact ® in the treatment of partial seizure epilepsy has been established in patients aged 4 and over The use of briviact ® in these age groups is supported by evidence from placebo-controlled studies in adult patients, as well as data from pharmacokinetic and open label safety studies in children aged 4 to 16 POS in children aged 4 to 16 years is similar to that in adults and has been shown to have a similar AED exposure response Body weight based dose adaptation has been established in the child population to achieve plasma concentrations similar to those in adults The safety and tolerability profile of briliact ® in children aged 4 to 16 years is similar to that in adults Based on the FDA's approval, patients aged 4 years and over in the United States can be provided with breviact ® tablets or oral solutions for POS treatment, which not only expands the clinical application of breviact ®, but also provides flexible drug delivery options, which is an important factor to consider when treating children Because the safety of the brivact ® injection in children has not been determined, the brivact ® injection is only suitable for epileptics aged 16 and over "As a pediatric neurologist, one of the most challenging aspects of treating childhood epilepsy is the need to quickly determine which AEDs are most helpful in controlling their epilepsy," explained Dr James wheless, director of the Epilepsy Program at the Institute of Neuroscience at Le bonheur children's hospital The consequences of poor epilepsy control can be extremely harmful, whether to the overall quality of life of patients and their families or to the development of children For parents and doctors, the real sense of urgency is to know whether a particular treatment is likely to succeed, to minimize some of the challenges associated with epilepsy, and to allow them to lead a normal and positive life Approved treatment options, such as briliact ®, will help improve the lives of children and their families, provide them with additional options and assist them with epilepsy treatment "We believe there is a real need for newer AEDs to support and maximize the potential for successful treatment of epileptic children," said Dr Jeff Wren, executive vice president and head of Neurology patient value at UCB The approval of briliact ® in the United States is an important milestone for child patients, family members, doctors, UCB and the wider epileptic population, and may provide additional benefits for today and the future of children We are very pleased to be able to provide a new pediatric treatment option to support patients on their way to anti epilepsy " We hope that the approval of this SNDA will benefit more epileptic children and help them to control the disease actively and effectively!