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Galcanezumab

Classification: A

Drug products: Emgality

ATC code: N02CD02

Substances: galcanezumab

Summary

Controlled clinical trials did not demonstrate any differences in efficacy or safety between men and women. No differences in galcanezumab pharmacokinetics are found between men and women and no sex differentiation in dosing is recommended by the pharmaceutical company.

Additional information

Migraine is twice as common in women as in men [1-3]. In a Swedish population-based study the one-year prevalence was 9.5% in men and 16.7 % in women [4] which is slightly lower than three months prevalence reported from the US [1].

Among adults with migraine, sex and gender differences were found in a cross-sectional longitudinal internet-based study (11 049 women, 4 084 men). Compared with men, women had significantly higher amount of monthly headache days, were more likely to have been diagnosed with migraine and to report headache-related disability and cutaneous allodynia. Among prescription medication users, women took more triptans than men, while men were more likely to take opioids and, besides oral formulations, use nasal spray and injectable medication. Men also used more daily oral preventive medication than women [5].

Women who have migraine with aura have an increased risk of ischemic stroke compared to women without migraine [6]. A prospective controlled study showed that in patients with active migraine, female sex was significantly associated with the risk of ischemic stroke [7].

It should be noted that most studies include more women than men, and the low number of men included can affect the ability to make statistically significant analyses.

Pharmacokinetics and dosing

A pooled population pharmacokinetic analysis (1 515 women, 375 men) showed that the pharmacokinetics of galcanezumab did not differ between men and women [8] and no sex differentiation in dosing has been recommended by the pharmaceutical company [9, 10].

Effects

No differences in migraine treatment effects of galcanezumab, between men and women, were shown in the pivotal studies according to the product information [9-12]. In a pivotal phase III study of galcanezumab in patients with chronic cluster headache, a pre-specified subgroup analysis was published in the supplemental information that showed that the treatment effect did not differ significantly based on patient’s sex [13]. Galcanezumab is currently not registered for the indication cluster headache in Europe [14].

Adverse effects

The incidence of side effects were similar in men and women according to the pharmaceutical company [10, 11].

EPAR Public assessment report [12] states that galcanezumab has a potential of negative impact on bone mass, which may be of certain interest in post-menopausal women with underlying osteoporosis.

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Updated: 2022-03-02

Date of litterature search: 2021-12-13

References

  1. Smitherman TA, Burch R, Sheikh H, Loder E. The prevalence, impact, and treatment of migraine and severe headaches in the United States: a review of statistics from national surveillance studies. Headache. 2013;53(3):427-36. PubMed
  2. Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010;11(4):289-99. PubMed
  3. Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343-9. PubMed
  4. Dahlöf C, Linde M. One-year prevalence of migraine in Sweden: a population-based study in adults. Cephalalgia. 2001;21:664-71. PubMed
  5. Lipton RB, Munjal S, Alam A, Buse DC, Fanning KM, Reed ML, Schwedt TJ, Dodick DW. Migraine in America Symptoms and Treatment (MAST) Study: Baseline Study Methods, Treatment Patterns, and Gender Differences. Headache. 2018;58(9):1408-1426. länk
  6. Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, et al. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005;64(6):1020-1026. länk
  7. Milhaud D, Bogousslavsky J, van Melle G, Liot P. Ischemic stroke and active migraine. Neurology. 2001;57(10):1805-11. PubMed
  8. Kielbasa W, Quinlan T. Population Pharmacokinetics of Galcanezumab, an Anti-CGRP Antibody, Following Subcutaneous Dosing to Healthy Individuals and Patients With Migraine. J Clin Pharmacol. 2020;60(2):229-239. PubMed
  9. Emgality (galcanezumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-07-21, cited 2021-12-13]
  10. Food and Drug Administration (FDA). Prescribing information - Emgality (galcanezumab). Drugs@FDA [www]. [updated 2019-12-05, cited 2021-12-13]. länk
  11. Food and Drug Administration (FDA). Drug Trials Snapshot: Emgality (galcanezumab). Drug Trials Snapshot [www]. [updated 2018-10-23, cited 2021-12-13]. länk
  12. EMA. Emgality. CHMP assessment report 2018-09-20. CHMP assessment report 2018-09-20
  13. Dodick DW, Goadsby PJ, Lucas C, Jensen R, Bardos JN, Martinez JM et al. Phase 3 randomized, placebo-controlled study of galcanezumab in patients with chronic cluster headache: Results from 3-month double-blind treatment. Cephalalgia. 2020;40(9):935-948. PubMed
  14. European Medicines Agency (EMA). Refusal of a change to the marketing authorisation for Emgality (galcanezumab. European Medicines Agency (EMA) [www]. [updated 2020-02-28, cited 2021-12-13]. länk
  15. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.] länk

Authors: Maria Ljungdahl

Reviewed by: Diana Rydberg, Carl-Olav Stiller

Approved by: Karin Schenck-Gustafsson