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EPIDYOLEX® DEMONSTRATED A CLINICALLY SIGNIFICANT REDUCTION IN CONVULSIVE SEIZURES## VS. PLACEBO IN DS PATIENTS1

Reduction in convulsive seizure frequency vs. placebo can be achieved as early as the second week of EPIDYOLEX® treatment (nominal p-value=0.03†)9

Primary endpoint: Reduction from baseline in monthly convulsive seizure## frequency1

18295_jazepi_no-cube-campaign-concept_ani_ds_graph_1.gif
ds - graph 01

Approximately 65% of the patients were taking concomitant clobazam*. Of the patients that were not taking clobazam*, the majority had previously taken and subsequently discontinued clobazam* treatment.

Primary endpoint: Reduction from baseline in monthly convulsive seizure## frequency1

18295_jazepi_no-cube-campaign-concept_ani_ds_graph_2.gif
ds - graph 02

Approximately 65% of the patients were taking concomitant clobazam*. Of the patients that were not taking clobazam*, the majority had previously taken and subsequently discontinued clobazam* treatment.

DS PATIENTS TREATED WITH EPIDYOLEX® BENEFITTED FROM MORE CONVULSIVE DROP SEIZURE##-FREE DAYS PER MONTH VS. PLACEBO1

In a post-hoc analysis

+1.3 – 2.2

Convulsive drop seizure##-free days per month1

EPIDYOLEX® 20 mg/kg/day

+2.7

Convulsive drop seizure##-free days per month1

EPIDYOLEX® 10 mg/kg/day

SUSTAINED SEIZURE REDUCTION VS. BASELINE WAS MAINTAINED OVER 3 YEARS5

High retention rate in OLE: 55% of patients with DS completed 3 years of treatment5

  • The mean modal dose of EPIDYOLEX® during the OLE trial was 22 mg/kg/day3
  • The maximum recommended dose in DS is 10 mg/kg twice daily (20 mg/kg/day)1
18295_jazepi_no-cube-campaign-concept_ani_ds_graph_3.gif

EPIDYOLEX® has been assessed in 5 Phase III clinical trials within Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) and Tuberous Sclerosis Complex (TSC) including 938 patients and 3 open-label extension studies.1,4

SIGNIFICANT SEIZURE REDUCTION

FOR LGS PATIENTS

LGS patients treated with EPIDYOLEX® sustained a reduction in seizures vs. baseline over 3 years.

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EXPLORE OUR

EFFICACY BEYOND SEIZURES

BECOME is a global outcomes survey of caregivers of 498 people with LGS or DS that assessed changes in behaviour, cognition and more with EPIDYOLEX® after ≥3 months of treatment, compared to the month prior to initiation.

Uncover the study

SIGNIFICANT SEIZURE REDUCTION

FOR TSC PATIENTS

Reduction in TSC-associated seizure frequency vs. placebo can be achieved as early as the second week of EPIDYOLEX® treatment.

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ABBREVIATIONS

CLB: Clobazam; DS: Dravet syndrome; GIC: Global Impression of Change; LGS: Lennox-Gastaut syndrome; OLE: open-label extension; RCT: randomised controlled trial; TSC: tuberous sclerosis complex.

* Clobazam currently does not have marketing authorisation in Norway.

† Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury.1

“ A month was defined as 28 days. No statistical analysis was performed for these data.

§ Analysis performed using overall population, in which 54.4% of patients were receiving concomitant CLB* treatment.4

## Convulsive seizures were defined as atonic, clonic, and tonic-clonic seizures.1

†† Assessed in overall population, where 64.4% of patients were receiving concomitant CLB*. p-values reported vs. placebo.

§§ Analysis performed using overall population, in which 68% of patients were receiving concomitant CLB* treatment.5

### TSC-associated seizures included: focal motor seizures with or without impairment of awareness, focal seizures evolving to bilateral motor seizures & generalised seizures (tonic-clonic, tonic, clonic, or atonic).

** The overall condition improved by at least one category on the seven-category Caregiver GIC scale. Improvements were based on measures of GIC scores at the last visit.10

  1. EPIDYOLEX® Summary of Product Characteristics. Approved: May 2023.
  2. Raga S, et al. Epileptic Disord. 2021;23(1):40–52.
  3. Marchese F, et al. SN Compr Clin Med. 2021;3:2167–2179.
  4. Patel AD, et al. Epilepsia. 2021;62(9):2228–2239.
  5. Scheffer IE, et al. Epilepsia. 2021;62(10):2505–2517.
  6. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  7. Berg A, et al. Epilepsy Research. 2023;107280:0920-1211.
  8. Privitera M, et al. Epilepsia. 2021;62:1130–1140.
  9. Cohen JM, et al. Epilepsia. 2021;62:2218–2227.
  10. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  11. Gray, RA and Whalley, BJ. Epileptic Disorders. 2020;(S1)22:S10–S15.
  12. Billakota S, et al. Curr Opin Neurol. 2019;32(2):220–226.
  13. Wu JY, et al. Epilepsia. 2022;63(5):1189–1199.

REFERENCES

  1. EPIDYOLEX® Summary of Product Characteristics. Approved: May 2023.
  2. Raga S, et al. Epileptic Disord. 2021;23(1):40–52.
  3. Marchese F, et al. SN Compr Clin Med. 2021;3:2167–2179.
  4. Patel AD, et al. Epilepsia. 2021;62(9):2228–2239.
  5. Scheffer IE, et al. Epilepsia. 2021;62(10):2505–2517.
  6. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  7. Berg A, et al. Epilepsy Research. 2023;107280:0920-1211.
  8. Privitera M, et al. Epilepsia. 2021;62:1130–1140.
  9. Cohen JM, et al. Epilepsia. 2021;62:2218–2227.
  10. Thiele EA, et al. Epilepsia. 2022;63(2):426–439.
  11. Gray, RA and Whalley, BJ. Epileptic Disorders. 2020;(S1)22:S10–S15.
  12. Billakota S, et al. Curr Opin Neurol. 2019;32(2):220–226.
  13. Wu JY, et al. Epilepsia. 2022;63(5):1189–1199.

ABBREVIATIONS

CLB: Clobazam; DS: Dravet syndrome; GIC: Global Impression of Change; LGS: Lennox-Gastaut syndrome; OLE: open-label extension; RCT: randomised controlled trial; TSC: tuberous sclerosis complex.

FOOTNOTES

* Clobazam currently does not have marketing authorisation in Norway.

† Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led or could have led to a fall or injury.1

“ A month was defined as 28 days. No statistical analysis was performed for these data.

§ Analysis performed using overall population, in which 54.4% of patients were receiving concomitant CLB* treatment.4

## Convulsive seizures were defined as atonic, clonic, and tonic-clonic seizures.1

†† Assessed in overall population, where 64.4% of patients were receiving concomitant CLB*. p-values reported vs. placebo.

§§ Analysis performed using overall population, in which 68% of patients were receiving concomitant CLB* treatment.5

### TSC-associated seizures included: focal motor seizures with or without impairment of awareness, focal seizures evolving to bilateral motor seizures & generalised seizures (tonic-clonic, tonic, clonic, or atonic).

** The overall condition improved by at least one category on the seven-category Caregiver GIC scale. Improvements were based on measures of GIC scores at the last visit.10