Emgality ® (galkanezumab)

För fullständig produktresumé för Emgality® se FASS.

Denna information är endast avsedd för sjukvårdspersonal verksam i Sverige och som svar på din fråga. Informationen nedan är på engelska

Emgality® ▼ (galcanezumab): Användning hos barn

Galcanezumabs säkerhet och effektivitet hos patienter under 18 år har inte fastställts.

Information from the label

The safety and efficacy of galcanezumab in children aged 6 to 18 years have not yet been established. No data are available.1

There is no relevant use of galcanezumab in children below the age of 6 years for the prevention of migraine.1

Clinical Trial Information

Patients <18 years of age at the time of screening were excluded from participation in the galcanezumab phase 2 and phase 3 clinical trials for migraine prevention.2-5

As such, the safety and efficacy of galcanezumab in patients younger than 18 years of age have not been established.

The REBUILD-1 and REBUILD-2 studies are designed to evaluate the safety and efficacy of galcanezumab in children and adolescents. Additional information on these studies are provided below.

REBUILD-1

The REBUILD-1 study is a phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of galcanezumab in children

  • 6 to 17 years of age

  • with a diagnosis of episodic migraine with or without aura as defined by the International Headache Society ICHD-3 guidelines (meeting criteria 1.1 or 1.2), and

  • with a history of migraine headaches of at least 6 months prior to screening.6-8

REBUILD-2

The REBUILD-2 study is a phase 3, randomized, double-blind, placebo-controlled clinical trial to determine the safety and efficacy of galcanezumab versus placebo for preventive treatment of chronic migraine in adolescents

  • 12 to 17 years of age, and

  • diagnosed with chronic migraine, defined by the ICHD-3 guidelines (meeting criteria 1.3) as a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.6,9,10

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

References

1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Stauffer VL, Dodick DW, Zhang Q, et al. Evaluation of galcanezumab for the prevention of episodic migraine: the EVOLVE-1 randomized clinical trial. JAMA Neurol. 2018;75(9):1080-1088. http://dx.doi.org/10.1001/jamaneurol.2018.1212

3. Skljarevski V, Matharu M, Millen BA, et al. Efficacy and safety of galcanezumab for the prevention of episodic migraine: results of the EVOLVE-2 phase 3 randomized controlled clinical trial. Cephalalgia. 2018;38(8):1442-1454. http://dx.doi.org/10.1177/0333102418779543

4. Detke HC, Goadsby PJ, Wang S, et al. Galcanezumab in chronic migraine: the randomized, double-blind, placebo-controlled REGAIN study. Neurology. 2018;91(24):e2211-e2221. http://dx.doi.org/10.1212/WNL.0000000000006640

5. Skljarevski V, Oakes TM, Zhang Q, et al. Effect of different doses of galcanezumab vs placebo for episodic migraine prevention: a randomized clinical trial. JAMA Neurol. 2018;75(2):187-193. http://dx.doi.org/10.1001/jamaneurol.2017.3859

6. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. http://dx.doi.org/10.1177/0333102417738202

7. A randomized, double-blind, placebo-controlled study of galcanezumab in patients 6 to 17 years of age with episodic migraine – the REBUILD-1 study. ClinicalTrials.gov. March 14, 2018. Accessed November 16, 2020. https://www.clinicaltrials.gov/ct2/show/NCT03432286

8. A study of galcanezumab (LY2951742) in participants 6 to 17 years of age with episodic migraine. Lilly Trial Guide website. Accessed November 16, 2020. https://trials.lillytrialguide.com/en-US/trial/3ZYuzhkEA0eK8qoWk6AUq2?conditionId=6aDBwPt6LDJj9rB2qnG4O7

9. A randomized, double-blind, placebo-controlled study of galcanezumab in adolescent patients 12 to 17 years of age with chronic migraine - the REBUILD-2 study. ClinicalTrials.gov. November 11, 2020. Accessed November 16, 2020. https://clinicaltrials.gov/ct2/show/NCT04616326

10. A study of galcanezumab (LY2951742) in participants 12 to 17 years of age with chronic migraine (REBUILD-2). Lilly Trial Guide Website. Accessed November 16, 2020. https://trials.lillytrialguide.com/en-US/trial/1mozTDMc0KoyNzh7Twsl5c?conditionId=6aDBwPt6LDJj9rB2qnG4O7

Glossary

ICHD-3 = International Classification of Headache Disorders – 3rd edition, beta

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2020 M11 16


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