UCB files BRIVIACT® (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patien
Monday, January 23, 2017
Posted by: Kristen Pappaterra
Brussels (Belgium), Atlanta (Georgia, USA), 19 January 2017 – 18:30 (CET): UCB has today announced the filing of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for BRIVIACT® (brivaracetam) CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.
BRIVIACT® is currently approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy1. The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) in adjunctive therapy clinical trials were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Please see additional BRIVIACT® Important Safety information below. Brivaracetam is not currently approved as monotherapy.
UCB submitted its supplemental application taking into account a recent General Advice Letter issued by the FDA2 which stated that it is “acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS”. The communication stipulates that, to support extrapolation, proposed dosages of a drug when used as monotherapy should result in exposures similar to those demonstrated to be safe and effective when the drug is used as adjunctive therapy and that adequate pharmacokinetic information must be provided “to demonstrate such similarity, taking into consideration possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug”. UCB has included this information within its BRIVIACT® monotherapy supplemental application.
“We are very pleased to be able to submit a label change for brivaracetam to the FDA, to include its use as monotherapy for partial-onset seizures. The FDA’s agreement to the principle of extrapolation from existing data in their assessment of antiepileptic drugs has enabled us to base this submission on the existing wealth of brivaracetam data, less than a year after its launch as an adjunctive therapy in the U.S., and could improve patient access to the medicine if approved,” said Professor Dr. Iris Loew-Friedrich, UCB’s Chief Medical Officer. “This submission, under the FDA’s extrapolation principle, allows us to use the strength of our brivaracetam clinical trials data, involving more than 2,400 adult patients with partial-onset seizures, and reinforces our longstanding commitment to develop and make available meaningful treatment solutions to improve the lives of people living with epilepsy.”
While the supplemental application of BRIVIACT® as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy in the U.S. has been accepted by the FDA, acceptance of this submission does not necessarily mean BRIVIACT®will be approved for this indication.
Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., 3 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. One third of patients with epilepsy live with uncontrolled seizures.
About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.
BRIVIACT® 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 U.S. and European Union, BRIVIACT® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).