UCB Announces BRIVIACT® (Brivaracetam) now Approved by FDA to Treat Partial-onset (Focal) Seizures in Pediatric Epilepsy Patients

Atlanta and Brussels (ots/PRNewswire) -

- BRIVIACT® (brivaracetam) CV oral formulations are approved as a
monotherapy or adjunctive therapy in patients four years of age and
older with partial-onset seizures

- Approval provides pediatric epilepsy patients a treatment option
which can be initiated at a therapeutic dose from day one

- Pediatric epilepsy is the most common, serious neurological
disorder among children and young adults, thought to affect nearly
470,000 children in the U.S[1],[2]

- Indication comes less than 2 years after the launch of BRIVIACT
in the U.S., building on existing adult monotherapy and adjunctive
therapy indications, and broadening clinical application for UCB's
newest anti-epilepsy drug

UCB announced today that the U.S. 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 pediatric 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
pediatric patients, BRIVIACT injection is indicated for the treatment
of partial-onset seizures only in patients 16 years of age and older.
Please see additional BRIVIACT Important Safety Information below.

As a result of the FDA's decision, children age four years and
older with partial-onset seizures in the U.S. 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 pediatric 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 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."

Epilepsy in childhood is a complex disorder that can have a
significant impact on many aspects of a child's development and
function. Social and societal stigma still associated with epilepsy
can be especially cruel for children. The prevalence of pediatric
epilepsy has been steadily increasing in the U.S.[3] Today, it is
estimated that nearly 470,000 children in the U.S. under the age of
18 have epilepsy, representing around a quarter of the total
worldwide population who develop the condition each year.[4] The U.S.
Centers for Disease Control and Prevention (CDC) estimate that 0.6
percent of children in the U.S. ages 0 to 17 have active epilepsy -
equivalent to six students in a school of 1000.[5] Despite its
growing prevalence, approximately 10 to 20 percent of pediatric
epilepsy patients experience inadequate seizure control with
available anti-epileptic drugs.[6],[7],[8] Alongside close
partnerships with educators, family members, and healthcare
providers, there is a need for newer AEDs with better seizure control
which can support and maximize a child's potential for academic
success.

"We believe there is a real need for newer AEDs to support and
maximize 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 pediatric 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 pediatric 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 pediatric patients are generally similar to
those seen in adult patients[9]. This principle of extrapolating
clinical data from well controlled studies in adults has been
recognized by the FDA as potentially addressing the challenge of
limited pediatric 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 pediatric patients age 4 to younger than 16 years
of age. Partial-onset seizures in pediatric 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 pediatric population to
achieve similar plasma concentrations as observed in adults. The
safety and tolerability profile for BRIVIACT in pediatric patients 4
to 16 years of age is generally similar to that seen with adult
patients.[9]

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.[9]

For additional medical information about BRIVIACT, patient
assistance, or any other information please visit
http://www.BRIVIACT.com or call 1-844-599-2273.

About Epilepsy[10],[11],[12],[5]

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. more than 3.4 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. Around one third of
patients with epilepsy currently 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 anti-epileptic 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.

About BRIVIACT[9],[13]

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 U.S., 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 pediatric 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.

Important Safety Information about BRIVIACT® in the U.S. [9]

Warnings and Precautions

- Suicidal Behavior and Ideation: Anti-epileptic drugs,
including BRIVIACT, increase the risk of suicidal behavior and
ideation. Monitor patients taking BRIVIACT for the emergence or
worsening of depression; unusual changes in mood or behavior; or
suicidal thoughts, behavior, or self-harm. Advise patients, their
caregivers, and/or families to be alert for these behavioral changes
and report them immediately to a healthcare provider.

- Neurological Adverse Reactions: BRIVIACT causes somnolence,
fatigue, dizziness, and disturbance in coordination. Somnolence and
fatigue-related adverse reactions were reported in 25% of adult
patients taking at least 50 mg per day of BRIVIACT compared to 14% of
adult patients taking placebo. Dizziness and disturbance in gait and
coordination were reported in 16% of adult patients taking at least
50 mg per day of BRIVIACT compared to 10% of adult patients taking
placebo. The risk is greatest early in treatment but can occur at any
time. Monitor patients for these signs and symptoms and advise them
not to drive or operate machinery until they have gained sufficient
experience on BRIVIACT.

- Psychiatric Adverse Reactions: BRIVIACT causes psychiatric
adverse reactions, including non-psychotic and psychotic symptoms.
These events were reported in approximately 13% of adult patients
taking at least 50 mg per day of BRIVIACT compared to 8% of adult
patients taking placebo. A total of 1.7% of adult patients taking
BRIVIACT discontinued treatment due to psychiatric reactions compared
to 1.3% of patients taking placebo. Psychiatric adverse reactions
were also observed in open-label pediatric trials and were generally
similar to those observed in adults. Advise patients to report these
symptoms immediately to a healthcare provider.

- Hypersensitivity: BRIVIACT can cause hypersensitivity reactions.
Bronchospasm and angioedema have been reported. Discontinue BRIVIACT
if a patient develops a hypersensitivity reaction after treatment.
BRIVIACT is contraindicated in patients with a prior hypersensitivity
reaction to brivaracetam or any of the inactive ingredients.

- Withdrawal of Anti-epileptic Drugs: As with all anti-epileptic
drugs, BRIVIACT should generally be withdrawn gradually because of
the risk of increased seizure frequency and status epilepticus.

DOSING CONSIDERATIONS

- Dose adjustments are recommended for patients with all stages of
hepatic impairment.

- When BRIVIACT is co-administered with rifampin, an increase in
the BRIVIACT dose is recommended.

ADVERSE REACTIONS

In adult adjunctive therapy placebo-controlled clinical trials,
the most common adverse reactions (at least 5% for BRIVIACT and at
least 2% more frequently than placebo) were somnolence and sedation,
dizziness, fatigue, and nausea and vomiting symptoms. Adverse
reactions reported in clinical studies of pediatric patients 4 years
to less than 16 years of age were generally similar to those in adult
patients.

BRIVIACT is a Schedule V controlled substance.

Please refer to full Prescribing Information at
http://www.briviact.com/briviact-PI.pdf

For more information on BRIVIACT®, contact 844-599-CARE (2273).

BRIVIACT® is a registered trademark of the UCB Group of Companies.

About UCB

UCB, Brussels, Belgium (http://www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development of
innovative medicines and solutions to transform the lives of people
living with severe diseases of the immune system or of the central
nervous system. With more than 7500 people in approximately 40
countries, the company generated revenue of EUR 4.2 billion in 2016.
UCB is listed on Euronext Brussels (symbol: UCB). Follow us on
Twitter: @UCB_news

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References:

1. Shinnar, S., Pellock, J.M. Update on the epidemiology and
prognosis of pediatric epilepsy. J Child Neurol. 2002;17(Suppl
1):S4-17.

2. Zack MM, Kobau R. National and State Estimates of the Numbers
of Adults and Children with Active Epilepsy - United States, 2015.
MMWR Morb Mortal Wkly Rep 2017;66:821-825. DOI:
http://dx.doi.org/10.15585/mmwr.mm6631a1 accessed 02 May 2018.

3. Datamonitor Healthcare. Epilepsy disease coverage. 2015.

4. Featherstone, V. Epilepsy in children and young people. Cerebra
- Positively Different. 2010. Available at:
http://eprints.hud.ac.uk/id/eprint/14522/1/Epilepsy%2520Brief.pdf
accessed 12th March 2018.

5. Centers for Disease Control and Prevention. Available at
https://www.cdc.gov/epilepsy/basics/fast-facts.htm Accessed 02 May
2018.

6. 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;60:14-17.

7. 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(11):1445-1452.

8. 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.

9. Briviact® U.S. Prescribing Information. Brussels, Belgium: UCB,
2018. https://www.briviact.com/briviact-PI.pdf

10. The Epilepsy Foundation of America. About epilepsy basics
http://www.epilepsy.com/learn/about-epilepsy-basics accessed accessed
02 May 2018.

11. The Epilepsy Foundation of America. What is epilepsy?
http://www.epilepsy.com/learn/epilepsy-101/what-epilepsy accessed 02
May 2018.

12. The Epilepsy Foundation of America. Who gets epilepsy?
http://www.epilepsy.com/learn/epilepsy-101/who-gets-epilepsy accessed
02 May 2018

13. Briviact® EU Prescribing Information. Brussels, Belgium: UCB,
2016. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Pro
duct_Information/human/003898/WC500200206.pdf accessed 02 May 2018.

ots Originaltext: UCB Pharma
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Corporate Communications
France Nivelle
Global Communications
UCB T +32-2-559-9178
France.nivelle@ucb.com. Jim Baxter
Neurology Communications
UCB
T +32-2-473-78-85-01
jim.baxter@ucb.com. Laurent Schots
Media Relations
UCB
T +32-2-559-92-64
laurent.schots@ucb.com. Investor Relations
Antje Witte
Investor Relations
UCB T +32-2-559-94-14
antje.witte@ucb.com. Isabelle Ghellynck
Investor Relations
UCB T +32-2-559-9588
isabelle.ghellynck@ucb.com

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