FDA approves Briviact for partial-onset seizures in paediatric epilepsy
The approval provides paediatric epilepsy patients a treatment option which can be initiated at a therapeutic dose from day one…
UCB has announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for the company’s newest anti-epileptic drug (AED) Briviact (brivaracetam) CV oral formulations indicated as monotherapy and adjunctive therapy in the treatment of partial onset (focal) seizures in patients age four years and older.
This approval provides clinicians with the convenient option to prescribe Briviact to their paediatric patients as a tablet or oral solution, providing flexible administration options which are important considerations when treating children.
As the safety of Briviact injection has not been established in paediatric patients, Briviact injection is indicated for the treatment of partial-onset seizures only in patients 16 years of age and older.
As a result of the FDA’s decision, children age four years and older with partial-onset seizures in the US can now be treated with Briviact. This extends the clinical application for Briviact which already has a similar indication for adults.
Briviact is the newest anti-epileptic drug (AED) in the synaptic vesicle protein 2A (SV2A) family of medicines – a class of medicines discovered and developed by UCB. Briviact demonstrates a high and selective affinity for SV2A in the brain. It is highly permeable and is rapidly and almost completely absorbed which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with Briviact for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.
“As a paediatric neurologist, one of the most challenging aspects in treating epilepsy in children is establishing, quickly, which anti-epilepsy drug will support them best in managing their seizures. The impact of poor seizure control can be extremely detrimental – both to the overall quality of life for patients and caregivers and for a child’s development. There is a real sense of urgency for parents and healthcare providers to know whether a particular therapeutic approach is likely to be successful, minimizing some of the challenges associated with epilepsy and potentially allowing them to live a normal and active life,” explained Dr. James Wheless, Director, Neuroscience Institute & Le Bonheur Comprehensive Epilepsy Program – Le Bonheur Children’s Hospital. “The availability of an approved treatment option, such as Briviact, has potential to help improve the lives of children and their families by providing an additional choice to support them in their epilepsy journey.”
“We believe there is a real need for newer AEDs to support and maximise the potential for success for children with epilepsy,” explained Jeff Wren, Executive Vice-President, Head of UCB’s Neurology Patient Value Unit. “The approval of Briviact in the U.S for paediatric patients represents an important milestone for patients, families, doctors, UCB, and the wider epilepsy community, and has the potential to provide additional value for patients – both today and for their future. We are very excited to be able to provide a new paediatric treatment choice, and we are proud to support patients as they progress on their epilepsy journey.”
The expanded FDA indication for Briviact is based on the principle of extrapolation of its efficacy data from adults to children and is supported by safety and pharmacokinetics data collected in children. Adverse reactions in paediatric patients are generally similar to those seen in adult patients. This principle of extrapolating clinical data from well-controlled studies in adults has been recognised by the FDA as potentially addressing the challenge of limited paediatric data availability.
The safety and effectiveness of Briviact in the treatment of partial-onset seizures have been established in patients four years of age and older. Use of Briviact in these age groups is supported by evidence from placebo-controlled partial-onset seizure studies of Briviact in adults with additional pharmacokinetic and open-label safety studies in paediatric patients age 4 to younger than 16 years of age. Partial-onset seizures in paediatric patients aged 4 to 16 years of age are similar to those in adults and a similar AED exposure-response relationship has been demonstrated. Weight-based dose adaptations have been established in the paediatric population to achieve similar plasma concentrations as observed in adults. The safety and tolerability profile for Briviact in paediatric patients 4 to 16 years of age is generally similar to that seen with adult patients.
The most common adverse reactions recorded for adults (at least 5 percent for Briviact and at least 2 percent more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.
Briviact (brivaracetam) is a new molecular entity that was rationally designed and developed by UCB.
Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT exerts its anticonvulsant activity is not known.
In the US Briviact (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. As the safety of Briviact injection in paediatric patients has not been established, Briviact injection is indicated for the treatment of partial-onset seizures only in adult patients (16 years of age and older).
In the European Union, Briviact is approved as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. The European Medicines Agency has different regulatory requirements from FDA for approval of monotherapy indications.