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Classification: A

Drug products: AJOVY

ATC code: N02CD03

Substances: fremanezumab


Studies before registration of fremanezumab reports equivalent efficacy, safety and pharmacokinetics in women and men. However, an analysis of subgroups indicates better efficacy in women.

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 (2 192 women, 354 men) showed a trend towards marginally higher exposures of fremanezumab in women than in men. However, this was not found to be statistically significant [8].

The pharmaceutical company reports no differences in fremanezumab pharmacokinetics between men and women [9] and no sex differentiation in dosing has been recommended [9, 10].


The pharmaceutical company reports no differences regarding effect of fremanezumab between men and women [11], although the EPAR Public assessment report [12] states lower effect in men showed in a subgroup analysis of two pivotal studies [13, 14]. A significant effect was found on all dosing regimens on reduction in monthly average headache days and in monthly average migraine days for women, but not for men. According to the assessment report the applicant responded that this probably emanated from the small sample size in the male subgroup (<50 men per study arm) and that the analyses performed in the main studies were not statistically powered to examine efficacy in patient subgroups [12].

In the pivotal studies and other studies using data from the phase III randomized clinical trials no analyses of sex differences are reported [15-25].

Adverse effects

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

Reproductive health issues

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

Updated: 2022-02-02

Date of litterature search: 2021-11-11


  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
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  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. Fiedler-Kelly JB, Cohen-Barak O, Morris DN, Ludwig E, Rasamoelisolo M, Shen H et al. Population pharmacokinetic modelling and simulation of fremanezumab in healthy subjects and patients with migraine. Br J Clin Pharmacol. 2019;85(12):2721-2733. PubMed
  9. AJOVY (fremanezumab). DailyMed [www]. [updated 2021-09-27, cited 2021-11-11]. länk
  10. Ajovy (fremanezumab). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-09-20, cited 2021-11-11]
  11. Food and Drug Administration (FDA). Drug Trials Snapshot: AJOVY (fremanezumab). Drug Trials Snapshoy [www]. [updated 2018-10-15, cited 2021-11-11]. länk
  12. EMA. Ajovy. Assessment report 2019-01-31. Assessment report 2019-01-31
  13. Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine. ClinicalTrialsGov [www]. [updated 2021-11-09, cited 2021-11-18]. länk
  14. Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine. ClinicalTrialsGov [www]. [updated 2021-11-09, cited 2021-11-18]. länk
  15. Brandes JL, Kudrow D, Yeung PP, Sakai F, Aycardi E, Blankenbiller T et al. Effects of fremanezumab on the use of acute headache medication and associated symptoms of migraine in patients with episodic migraine. Cephalalgia. 2020;40(5):470-477. PubMed
  16. Dodick DW, Silberstein SD, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al. Effect of Fremanezumab Compared With Placebo for Prevention of Episodic Migraine: A Randomized Clinical Trial. JAMA. 2018;319(19):1999-2008. PubMed
  17. Silberstein SD, Cohen JM, Yang R, Gandhi SK, Du E, Jann AE et al. Treatment benefit among migraine patients taking fremanezumab: results from a post hoc responder analysis of two placebo-controlled trials. J Headache Pain. 2021;22(1):2. PubMed
  18. Silberstein SD, Cohen JM, Seminerio MJ, Yang R, Ashina S, Katsarava Z. The impact of fremanezumab on medication overuse in patients with chronic migraine: subgroup analysis of the HALO CM study. J Headache Pain. 2020;21(1):114. PubMed
  19. Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, Blankenbiller T et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017;377(22):2113-2122. PubMed
  20. Silberstein SD, McAllister P, Ning X, Faulhaber N, Lang N, Yeung P et al. Safety and Tolerability of Fremanezumab for the Prevention of Migraine: A Pooled Analysis of Phases 2b and 3 Clinical Trials. Headache. 2019;59(6):880-890. PubMed
  21. Ferrari MD, Diener HC, Ning X, Galic M, Cohen JM, Yang R et al. Fremanezumab versus placebo for migraine prevention in patients with documented failure to up to four migraine preventive medication classes (FOCUS): a randomised, double-blind, placebo-controlled, phase 3b trial. Lancet. 2019;394(10203):1030-1040. PubMed
  22. Lipton RB, Cohen JM, Galic M, Seminerio MJ, Yeung PP, Aycardi E et al. Effects of fremanezumab in patients with chronic migraine and comorbid depression: Subgroup analysis of the randomized HALO CM study. Headache. 2021;61(4):662-672. PubMed
  23. Goadsby PJ, Silberstein SD, Yeung PP, Cohen JM, Ning X, Yang R et al. Long-term safety, tolerability, and efficacy of fremanezumab in migraine: A randomized study. Neurology. 2020;95(18):e2487-e2499. PubMed
  24. Buse DC, Gandhi SK, Cohen JM, Ramirez-Campos V, Cloud B, Yang R et al. Improvements across a range of patient-reported domains with fremanezumab treatment: results from a patient survey study. J Headache Pain. 2020;21(1):109. PubMed
  25. Winner PK, Spierings ELH, Yeung PP, Aycardi E, Blankenbiller T, Grozinski-Wolff M et al. Early Onset of Efficacy With Fremanezumab for the Preventive Treatment of Chronic Migraine. Headache. 2019;59(10):1743-1752. PubMed
  26. 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