Health Canada Approves BRIVLERA® (brivaracetam) to treat partial-onset seizures in pediatric epilepsy patients

• 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.

BRIVLERA® (brivaracétam) Logo (CNW Group/UCB Canada Inc.)

"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/.

References:
^i	Public Health Agency of Canada. "Scope (Prevalence And Incidence) Of Neurological Conditions". Mapping Connections: An Understanding Of Neurological Conditions In Canada. 2014. Available at: http://www.phac-aspc.gc.ca/publicat/cd-mc/mc-ec/section-3-eng.php. Last accessed on May 12, 2020.
^ii	Statistics Canada. Table  105-1300 –  Neurological conditions, by age group and sex, household population aged 0 and over, 2010/2011,  CANSIM (database).
^iii	BRIVLERA® Canadian Product Monograph. Available at: https://www.ucb-canada.ca/_up/ucbpharma_ca_en/documents/2020-05-01%20brivlera-pm-en.pdf.
^iv	Berg AT, Vickrey BG, Testa FM, Levy SR, Shinnar S, DiMario F, et al. How long does it take for epilepsy to become intractable? A prospective investigation. Ann Neurol. 2006;60:73-79.
^v	Berg A, Shinnar S, Levy S, Testa F, Smith-Rapaport S, Beckerman B. Early development of intractable epilepsy in children: a prospective study. Neurology. 2001;56:1445-1452.
^vi	Geerts A, Arts WF, Stroink H, Peeters E, Brouwer O, Peters B, et al. Course and outcome of childhood epilepsy: a 15-y follow-up of the Dutch study of epilepsy in childhood. Epilepsia. 2010;51:1189–97.
^vii	World Health Organization. Epilepsy. Available at: https://www.who.int/news-room/fact-sheets/detail/epilepsy. June 2019. Last accessed on May 12, 2020.
^viii	Epilepsy Ontario. What is Epilepsy?  Available at: https://epilepsyontario.org/about-epilepsy/what-is-epilepsy/ Last accessed on May 12, 2020.
^ix	World Health Organization.  Neurological Disorders. Available at: https://www.who.int/mental_health/neurology/neurological_disorders_report_web.pdf. Last accessed on May 12, 2020.
^x	Carmant L., Stafstrom Carl E. Seizures and Epilepsy: An Overview for Neuroscientists. Cold Spring Harb Perspect Med. 2015 Jun; 5(6): a022426 Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4448698/ Last accessed on May 20, 2020
^xi	Kaminski R.M., Gillard M. & Klitgaard H. Targeting SV2A for Discovery of Antiepileptic Drugs. Jasper's Basic Mechanisms of The Epilepsies. 4th Edition, 2012:1-12
^xii	Mazzuferi M., Kumar G., van Eyll J., Danis B., Foerch P.& Kaminski R.M. Nrf2 defense pathway: Experimental evidence for its protective role in epilepsy. Ann Neurol. 2013 74(4):560-568

SOURCE UCB Canada Inc.

Ben Faienza, UCB Canada Inc. , Tel: [phone], [email protected]