Pediatric Data | BRIVIACT® (brivaracetam) CV

BRIVIACT^® (brivaracetam) CV is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.¹

RETENTION

Long-term retention data in pediatric and adult patients
with focal seizures

2 years
in pediatric patients

~64% (89/168) remained on BRIVIACT
2 years after starting treatment in a phase 2a and phase 3a open-label trial²

View study design

STUDY DESIGN:
Pooled data from phase 2a and phase 3a open-label trials of BRIVIACT in patients aged ≥1 month to <17 years (N=219), uncontrolled by 1 to 3 AEDs. Of the 219 patients, 168 had focal seizures. After dose adjustment, patients received BRIVIACT 1 to 5 mg/kg/day (maximum 200 mg/day).²

5 years in adults

~50% remained on BRIVIACT
5 years after starting treatment in an open-label, long-term follow-up trial³*

View study design

STUDY DESIGN:
Modified safety population included adult patients with epilepsy from phase 2b and phase 3 trials, uncontrolled by 1-3 antiepileptic drugs (AEDs), who continued into the open-label, long-term, follow-up trial taking BRIVIACT 50-200 mg/day (N=2,051). Limited exposure was seen at the later time points; 41 patients (1.7%) continued treatment for ≥8 years, and 3 patients (0.1%) continued for 8.5 years.³

*Patients who discontinued due to reasons other than lack of efficacy or adverse events were censored from the analysis.

This long-term retention data is an estimation of how long patients have remained on treatment in select BRIVIACT clinical studies. Conclusions of long-term efficacy or safety should not be drawn based on this data.

EFFICACY

BRIVIACT efficacy extrapolated for pediatric patients¹

Efficacy in adults was established without a titration period¹

View adult efficacy data

Adult pivotal trial design¹

Effectiveness was established in 3 fixed-dose, randomized, double-blind, placebo-controlled, multicenter studies, which included 1550 adult patients
Enrolled adult patients had focal seizures that were not adequately controlled by 1 to 2 concomitant AEDs
Patients taking concomitant levetiracetam were excluded from Study 3

BRIVIACT efficacy was also studied in pediatric patients^1,4

Pediatric study design⁴

Phase 2a, open-label, single-arm, fixed 3-step dose-escalation trial
Short-term safety and tolerability, pharmacokinetics, preliminary efficacy of BRIVIACT oral solution. Efficacy analyses were exploratory
Pediatric patients 1 month to <16 years of age
1-week baseline period, 3-week evaluation period

View additional study design

In the treatment period, BRIVIACT oral solution dosage was divided into 2 daily doses and increased each week to approximately 0.8, 1.6, and 3.2 mg/kg/day for patients aged ≥8 years, and 1.0, 2.0, and 4.0 mg/kg/day for patients aged <8 years⁴
99 patients were enrolled in the trial; 52 patients with focal seizures were included in the safety analysis, and 50 were included in the efficacy analysis. Only those patients experiencing seizures in the one-week baseline period (n=37) were included in the seizure reduction and responder rate analyses. All 50 focal seizure patients were included in the seizure freedom analysis⁴

View demographic data

BRIVIACT was studied in a challenging pediatric population with focal seizures⁴

PRIOR AEDs

CONCOMITANT AEDs

Pediatric trial results⁴

EFFICACY WAS EVALUATED OVER A 3-WEEK PERIOD

30^%

OF PATIENTS

experienced a ≥50% reduction in seizure days from baseline*

Based on treatment responses seen in patients with focal seizures (11/37; <16 years old).

24^%

OF PATIENTS

achieved complete seizure freedom over a 3-week period^†

As seen in patients (12/50) with focal seizures.

*Patients without seizure in baseline were excluded. Number of seizure days standardized to a 28-day duration.

^†With or without secondary generalization and no primary generalized seizures at baseline.

SAFETY

In adult adjunctive trials, most adverse events with BRIVIACT were reported to be mild or moderate²

The safety profile of BRIVIACT was established in adults in phase 3 placebo-controlled trials¹

View most common adverse reactions in adults

Most common adverse reactions that occurred in ≥5% for BRIVIACT
and at least 2% more frequently than placebo¹

The safety profile for pediatric patients was
similar to adults¹

BRIVIACT has been shown to be generally well tolerated for infants 1 month
of age and older^1,2

The most common drug-related treatment-emergent adverse events (TEAEs) in pooled pediatric studies (≥5%)²

View phase 2a and 3a
open-label study design

STUDY DESIGN:
Pooled safety data from phase 2a and phase 3a open-label trials of BRIVIACT in patients aged 1 month to <17 years (N=219), uncontrolled by 1 to 3 AEDs. Of the 219 patients, 168 had focal seizures. After dose adjustment, patients received BRIVIACT 1 to 5 mg/kg/day (maximum 200 mg/day).²

BRIVIACT injection safety and tolerability is consistent with oral formulations²

The safety and tolerability of BRIVIACT IV has been evaluated as a 15-minute infusion or a bolus (up to 2-minute) injection in an open-label study in children aged 2 months to <16 years with epilepsy²
The safety and pharmacokinetics of BRIVIACT were similar in the infusion and bolus injection groups²

Adverse reactions with BRIVIACT injection in adult and pediatric patients were generally similar to those observed with BRIVIACT tablets. Other adverse events that occurred in adult patients who received BRIVIACT injection included dysgeusia, euphoric mood, feeling drunk, and infusion site pain¹

BEHAVIOR & COGNITION

Behavioral and cognitive stability with BRIVIACT: Pediatric measures were generally unchanged from baseline²

Based on 2 established neurological measurement tools^5,6

Parents or caregivers completed the BRIEF^® and Achenbach Child Behavior Checklist (CBCL) surveys at regular intervals during the long-term, phase 3a, follow-up study. The version appropriate for the patient’s age at each visit was completed^2,7

View study design

Study design for evaluating BRIEF^® and Achenbach CBCL^2,7

Pooled interim analysis from phase 2a and 3a open-label trials
Included pediatric patients 1 month to <17 years (N=219) uncontrolled by 1 to 3 AEDs
Of the 219 patients, 168 had focal seizures
Parents or caregivers completed the BRIEF^® and Achenbach CBCL surveys at regular intervals during the long-term, phase 3a, follow-up study. The version appropriate for the patient’s age at each visit was completed
AED changes were permitted over the duration of the long-term follow-up study
Additional factors may influence measures of behavior and cognition

Executive function and self-regulation categories^* remained stable for the majority of school-aged children (aged 5 to ≤17 years), relative to baseline²

BRIEF^® GLOBAL EXECUTIVE COMPOSITE SCORE CATEGORY CHANGES (N=92)^2*

*T-score categories were defined as “normal” (0 to <50), “borderline” (50 to <65), and “clinically significant” (≥65).

BRIEF=Behavior Rating Inventory of Executive Function.

Emotional, behavioral, and social problem categories^† remained stable among the majority of school-aged children (aged 6 to <17 years), relative to baseline²

SHIFT IN CHILD BEHAVIOR CHECKLIST T-SCORE CATEGORIES (N=127)^†

A similar trend was observed among patients aged 1½ months to 5 years who were assessed by a separate CBCL.

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. 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.¹

DOSING

A therapeutic dose on day 1 with the simplicity of no required titration¹

For your pediatric patients with focal seizures, you can start with a therapeutic dose on day 1 with BRIVIACT, and have room to adjust if needed based on clinical response and tolerability.

The recommended dosing regimen is dependent upon body weight for patients weighing less than 50 kg.

Recommended dosage

Multiple formulations for pediatric patients¹

SIMPLE 1:1 DOSE CONVERSION

Oral solution 10 mg/mL:

300-mL bottles

Tablets*:

60-count bottles

*10-mg tablets are also available.

Injection solution
50 mg/5 mL:

Single-use vial undiluted injection or infusion

Products not shown at actual size.

BRIVIACT oral solution and tablets¹

Can be given with or without food

Tablets should be swallowed whole with liquid. They should not be chewed or crushed

No blood level, respiratory, or cardiac monitoring required

Intravenous injection only¹

BRIVIACT injection may be used when oral administration is temporarily not feasible
BRIVIACT injection should be administered intravenously at the same dosage and same frequency as BRIVIACT tablets and oral solution
No refrigeration required
- Can be stored in Pyxis or Omnicell systems

BRIVIACT injection offers rapid administration

Median T_max following a
2-minute bolus (administered undiluted) is <5 minutes⁸

Can be administered intravenously over 2 to 15 minutes¹

No dilution required¹

COPAY/SAVINGS

Multiple resources to provide savings and support for
BRIVIACT patients

UCB is committed to making BRIVIACT accessible for the majority of eligible patients across the US*

BRIVIACT is covered by most commercial plans.

9 out of 10 commercial patients
have formulary access to BRIVIACT²

BRIVIACT Patient Savings Program

Eligible patients pay as little as $10 per 30-day supply of BRIVIACT with the BRIVIACT Patient Savings Program.*

See eligibility criteria and terms

Eligibility Criteria and Terms

*Patients are responsible for a minimum of $10 out-of-pocket expense per 30-day supply. This card will be applied to any remaining out-of-pocket expense up to a maximum of $1300. Most patients who have commercial prescription insurance are eligible. If you have any questions regarding your eligibility or benefits or if you wish to discontinue your participation, call the BRIVIACT Savings Program at 1-888-786-5879 (8:30 AM – 5:30 PM EST, Monday-Friday and 8:30 AM – 2:30 PM EST, Saturday). This savings card is not valid for use by patients who are covered by any federally funded or state-funded healthcare program (including, but not limited to, Medicare [Part D and Medigap] and those who are Medicare-eligible and enrolled in an employer-sponsored health plan for retirees, Medicaid, any state pharmaceutical assistance program, TRICARE, VA, or DoD), or for cash-paying patients. Offer good only in the U.S., including Puerto Rico. This card is good for use only with a valid BRIVIACT prescription consistent with the approved FDA labeling at the time the prescription is filled by the pharmacist and dispensed to the patient. The maximum annual benefit amount is $1300 per calendar year. Void where prohibited by law, taxed, or restricted. This offer cannot be combined with any other promotional offer. UCB, Inc. reserves the right to rescind, revoke, or amend this offer without notice at any time. No cash value. Not eligible for sale, purchase, trade, or counterfeit.

UCB is committed to making BRIVIACT accessible for the majority of eligible patients
across the US*

BRIVIACT is covered by most commercial plans.

9 out of 10 commercial patients
have formulary access to BRIVIACT²