• BRIVLERA is approved as an adjunctive therapy in patients four years of age and older with partial-onset seizures after conventional therapy.
• Health?Canada's?approval of BRIVLERA provides pediatric epilepsy patients with a treatment option which can be initiated at a therapeutic dose from day one.
• BRIVLERA has been available in?Canada?for the treatment of epilepsy in adults (>18 years of age) since 2016, broadening clinical application for UCB's newest anti-epilepsy drug.
• Epilepsy affects approximately 260,000 Canadians[i], of which 75-85% of patients are diagnosed before age 18ⁱⁱ, making pediatric epilepsy the most common, serious neurological disorder among children and young adults.

OAKVILLE, ON,?July 29, 2020?/CNW/ -?UCB Canada Inc. announced today that Health Canada has approved BRIVLERA? (brivaracetam) as an adjunctive therapy in the management of partial-onset seizures in patients 4 years of age and older with epilepsy who are not satisfactorily controlled with conventional therapy.^iii?This approval provides clinicians with a child-friendly option to prescribe BRIVLERA to their pediatric patients as a tablet or oral solution, offering flexible administration options which are important considerations when treating children. BRIVLERA has been approved in?Canada?for the treatment of epilepsy?in adults (>18 years of age) since 2016.

"Pediatric epilepsy can have a significant impact on a child's development and quality of life. New treatment options, such as BRIVLERA, are important because they expand the opportunity to provide children with individualized treatment aimed at achieving seizure control," said Dr.?Andrea Andrade, Neurologist and Epileptologist, Medical Director, Pediatric Epilepsy Program at Children's Hospital in?London, Ontario.

Epilepsy is a complex disorder affecting approximately 260,000 Canadiansⁱ, of which 75-85% are diagnosed before age 18ⁱⁱ, making pediatric epilepsy the most common, serious neurological disorder among children and young adults. It is estimated that 42,000 children in?Canada?under the age of 18 have epilepsy.ⁱⁱ?Despite its growing prevalence, approximately 10 to 20 per cent of pediatric epilepsy patients experience inadequate seizure control with available anti-epileptic drugs.^{iv, v, vi} "For children and families living with epilepsy, one of the most frightening things about seizures is their unpredictability," said?Paul Raymond, Chief Executive Officer, Epilepsy Ontario. "Having a new treatment for partial-onset seizures may help to minimize some of the anxiety and challenges associated with epilepsy in children and allow them to live a normal and active life." BRIVLERA 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. It is easily and extensively absorbed by the body and rapidly permeates the brain where it demonstrates high and selective affinity for SV2A. This may contribute to its anticonvulsant effects. BRIVLERA has a favourable tolerability profile and a titration period is not required when initiating treatment with BRIVLERA for adjunctive therapy. This allows clinicians to start patients within the therapeutic dose range from the first day of treatment. BRIVLERA was approved by Health Canada based on the principle of extrapolation of its efficacy data from adults to children and is supported by pharmacokinetic and safety data collected in children. This principle of extrapolating clinical data from well controlled studies in adults has been recognized by Health Canada as potentially addressing the challenge of limited pediatric data availability. The safety and tolerability profile of BRIVLERA in children 4 years and older is generally similar to that seen with adult patients.^?i Use of BRIVLERA in pediatric and adolescent patients is supported by evidence from placebo-controlled partial-onset seizure studies of BRIVLERA in adults with additional pharmacokinetic and open-label safety studies in pediatric aged 4 to 17 years of age. Weight-based dose adaptations have been established in the pediatric population to achieve similar plasma concentrations as observed in adults.^i??Specific weight-based dosing has been established which allows clinicians to tailor BRIVLERA treatment to individual patient needs. About Epilepsy in?Canada
Epilepsy is a chronic neurological disorder affecting approximately 50 million people worldwide^vii, including about 1 in 100 people in?Canada^?viii. While epilepsy has the highest rate of new cases in seniors and young children, it can affect people of any age, race and sex^viii.?Next to migraine headaches, epilepsy is the most common neurological disorder^ix. It is defined as one or more unprovoked seizures with a risk of future seizures. Around one third of people with epilepsy live with uncontrolled seizures.^x About BRIVLERA
BRIVLERA (brivaracetam) is a newer 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 BRIVLERA exerts its anticonvulsant activity is not known.ⁱ In?Canada, BRIVLERA is indicated for the adjunctive treatment of partial-onset seizures in patients with epilepsy 4 years of age and older. As the safety of BRIVLERA injection in pediatric patients has not been established, BRIVLERA injection is indicated for the treatment of partial-onset seizures only in adult patients (18 years of age and older).ⁱ Brivaracetam (marketed as BRIVIACT?) is also approved in?the United States?and the European Union. Important and complete safety information about BRIVLERA can be found by accessing the?product monograph at?https://www.ucb-canada.ca/en/Our-Medicines/overview. About UCB in Epilepsy?
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of anti-epileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. We contribute to cutting-edge research leading to the identification of novel AED targets^xi?and validation of mechanisms that will pave the way for future therapeutic solutions for epilepsy patients^xii. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. We are proud supporters of Canadian researchers and to date, more than 6,000 Canadians have participated in over 20 global clinical trials through leading centres across the country.?At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy. For more information, please visit?https://www.ucb-canada.ca/. SOURCE UCB Canada Inc. For further information: Ben Faienza, UCB Canada Inc. , Tel: (905) 287-5115,?ben.faienza@ucb.com