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  4. Was alopecia reported in Emgality® (galcanezumab-gnlm) clinical trials?
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Emgality ® (galcanezumab-gnlm) injection

100 mg/mL, 120 mg/mL

Full Prescribing Information

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

Was alopecia reported in Emgality® (galcanezumab-gnlm) clinical trials?

Treatment-emergent alopecia was reported in <1% of patients treated with galcanezumab in phase 3, double-blind, placebo-controlled trials. Events were mild or moderate in severity, and no galcanezumab-treated patients discontinued due to alopecia.

US_cFAQ_GLC116_TEAE_ALOPECIA
US_cFAQ_GLC116_TEAE_ALOPECIAen-US

Summary of Alopecia in the Phase 3, Double-Blind, Placebo-Controlled Galcanezumab Clinical Trials

Galcanezumab has been studied in migraine prevention and cluster headache.1-7 A brief overview of the phase 3, double-blind, placebo-controlled studies can be found in the Appendix. Treatment-emergent adverse events related to alopecia for each population are summarized separately in the following sections.

Additional information on alopecia and biological plausibility can be found in the Appendix.

Alopecia in the Phase 3, Double-Blind, Placebo-Controlled Migraine Prevention Studies

The incidence and severity of alopecia during the double-blind treatment phase of EVOLVE-1, EVOLVE-2, and REGAIN for migraine prevention are summarized in Incidence and Severity of Treatment-Emergent Alopecia Events in EVOLVE-1, EVOLVE-2, and REGAIN Studies: Double-Blind Treatment Phase.


Incidence and Severity of Treatment-Emergent Alopecia Events in EVOLVE-1, EVOLVE-2, and REGAIN Studies: Double-Blind Treatment Phase8

TEAE

PBO
(N=1451)
n (%)

GMB 120 mg
(N=705)
n (%)

GMB 240 mg
(N=730)
n (%)

Alopecia

Incidence

5 (0.3)

3 (0.4)

4 (0.6)

Severity 

Mild

4 (0.3)

3 (0.4)

3 (0.4)

Moderate

1 (0.1)

0 (0.0)

1 (0.1)

Severe

0 (0.0)

0 (0.0)

0 (0.0)

Alopecia areata

Incidence

0 (0.0)

1 (0.1)

0 (0.0)

Severity

Mild

0 (0.0)

1 (0.1)

0 (0.0)

Moderate

0 (0.0)

0 (0.0)

0 (0.0)

Severe

0 (0.0)

0 (0.0)

0 (0.0)

Abbreviations: GMB = galcanezumab; PBO = placebo; TEAE = treatment-emergent adverse event.

The alopecia events were mild or moderate in severity, with no severe events reported. One placebo-treated patient from the REGAIN study discontinued due to treatment-emergent alopecia.8

No patients experienced treatment-emergent alopecia during double-blind treatment in the CONQUER study.8

Alopecia in the Phase 3, Double-Blind, Placebo-Controlled Cluster Headache Studies

No patients experienced treatment-emergent alopecia during double-blind treatment in the phase 3 cluster headache studies.8

Postmarketing Spontaneous Reports

Based on postmarketing spontaneous reports from the Eli Lilly and Company spontaneous adverse event (AE) database received through September 27, 2024,

  • alopecia has been rarely reported (≥0.01% and <0.1%), and
  • alopecia areata and androgenetic alopecia have been very rarely reported (<0.01%).8

Postmarketing data do not necessarily represent the rate of occurrence of an AE in a treated population, but they represent a reporting rate of a particular AE to the company. Spontaneous reporting of AEs can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an event.9

Spontaneous reporting has limited use due to

  • lack of control population
  • underreporting or reporting bias, and
  • missing or incomplete information regarding medical history or concomitant medications.9

Enclosed Prescribing Information

EMGALITY® (galcanezumab-gnlm) injection, for subcutaneous use, Lilly

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1Stauffer 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

2Skljarevski 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

3Detke 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

4Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825. http://dx.doi.org/10.1016/S1474-4422(20)30279-9

5Dodick DW, Goadsby PJ, Lucas C, 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. http://dx.doi.org/10.1177/0333102420905321

6Goadsby PJ, Dodick DW, Leone M, et al. Trial of galcanezumab in prevention of episodic cluster headache. N Engl J Med. 2019;381(2):132-141. http://dx.doi.org/10.1056/NEJMoa1813440

7Láinez MJA, Schoenen J, Stroud C, et al. Tolerability and safety of galcanezumab in patients with chronic cluster headache with up to 15 months of galcanezumab treatment. Headache. 2022;62(1):65-77. https://doi.org/10.1111/head.14234

8Data on file, Eli Lilly and Company and/or one of its subsidiaries.

9Goldman SA. Limitations and strengths of spontaneous reports data. Clin Ther. 1998;20(suppl 3):C40-C44. http://dx.doi.org/10.1016/S0149-2918(98)80007-6

10Kinori M, Bertolini M, Funk W, et al. Calcitonin gene-related peptide (CGRP) may award relative protection from interferon-gamma-induced collapse of human hair follicle immune privilege. Exp Dermatol. 2012;21(3):223-226. http://dx.doi.org/10.1111/j.1600-0625.2011.01432.x

11Pi L-Q, Jin X-H, Hwang ST, et al. Effects of calcitonin gene-related peptide on the immune privilege of human hair follicles. Neuropeptides. 2013;47(1):51-57. http://dx.doi.org/10.1016/j.npep.2012.07.008

12Samuelov L, Kinori M, Bertolini M, et al. Neural controls of human hair growth: calcitonin gene-related peptide (CGRP) induces catagen. J Dermatol Sci. 2012;67(2):153-155. http://dx.doi.org/10.1016/j.jdermsci.2012.04.006

13Suh DH, Eun HC. The effect of calcitonin gene-related peptide on hair growth in vitro. Ann Dermatol. 1995;7(4):308-312. https://doi.org/10.5021/ad.1995.7.4.308

14Paus R, Ito N, Takigawa M, Ito T. The hair follicle and immune privilege. J Investig Dermatol Symp Proc. 2003;8(2):188-194. http://dx.doi.org/10.1046/j.1087-0024.2003.00807.x

15Blume-Peytavi U, Blumeyer A, Tosti A, et al. S1 guideline for diagnostic evaluation in androgenetic alopecia in men, women and adolescents. Br J Dermatol. 2011;164(1):5-15. http://dx.doi.org/10.1111/j.1365-2133.2010.10011.x

16Birch MP, Messenger JF, Messenger AG. Hair density, hair diameter and the prevalence of female pattern hair loss. Br J Dermatol. 2001;144(22):297–304. http://dx.doi.org/10.1046/j.1365-2133.2001.04018.x

17Norwood OT. Incidence of female androgenetic alopecia (female pattern alopecia). Dermatol Surg. 2001;27(1):53–54. https://www.ncbi.nlm.nih.gov/pubmed/11231244

18Varothai S, Bergfeld WF. Androgenetic alopecia: an evidence-based treatment update. Am J Clin Dermatol. 2014;15(3):217-230. http://dx.doi.org/10.1007/s40257-014-0077-5

19Gan DCC, Sinclair RD. Prevalence of male and female pattern hair loss in Maryborough. J Investig Dermatol Symp Proc. 2005;10(3):184–189. https://doi.org/10.1111/j.1087-0024.2005.10102.x

20Olsen EA, Messenger AG, Shapiro J, et al. Evaluation and treatment of male and female pattern hair loss. J Am Acad Dermatol. 2005;52(2):301–311. https://doi.org/10.1016/j.jaad.2004.04.008

21Hamilton JB. Patterned loss of hair in man: types and incidence. Ann N Y Acad Sci. 1951;53(3):708–728. http://dx.doi.org/10.1111/j.1749-6632.1951.tb31971.x

22Alonso L, Fuchs E. The hair cycle. J Cell Sci. 119:391-393. http://dx.doi.org/10.1242/jcs02793

23Stenn KS, Paus R. Controls of hair follicle cycling. Physiol Rev. 2001;81(1):449-494. http://dx.doi.org/10.1152/physrev.2001.81.1.449

24Cristoph T, Müller-Röver S, Audring H, et al. The human hair follicle immune system: cellular composition and immune privilege. Br J Dermatol. 2000;142(5):862-873. https://doi.org/10.1046/j.1365-2133.2000.03464.x

25Pozo-Rosich P, Detke HC, Wang S, et al. Long-term treatment with galcanezumab in patients with chronic migraine: results from the open-label extension of the REGAIN study. Curr Med Res Opin. 2022;38(5):731-742. https://doi.org/10.1080/03007995.2022.2059975

26Reuter U, Lucas C, Dolezil D, et al. Galcanezumab in patients with multiple previous migraine preventive medication category failures: results from the open-label period of the CONQUER trial. Adv Ther. 2021;38:5465-5483. http://dx.doi.org/10.1007/s12325-021-01911-7

27Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. http://dx.doi.org/10.1186/s12883-018-1193-2

Appendix

Biological Plausibility of Alopecia With Galcanezumab Use

There are conflicting reports of the role of calcitonin-gene related peptide (CGRP) on hair growth in the published literature.10-13

Calcitonin-gene related peptide

  • has been shown to interact with peptides that control hair growth10-13
  • has immunomodulatory properties11
  • might be an important regulatory factor for maintenance and restoration of immune privilege at the proximal epithelium of hair follicles14
  • suppresses antigen presentation to lymphocytes and slows down their proliferation and reactivity, and11
  • expression decreases in alopecia areata lesions.14

Therefore, modulating CGRP function may have potential impact on the hair follicle. Additional Published Information on Alopecia provides further discussion on this topic. 

Additional Published Information on Alopecia

Alopecia is more common in women than men, and its prevalence increases with age.15 In the United Kingdom and United States, the prevalence of alopecia is

  • 3% to 6% in women <30 years of age, and
  • 29% to 42% in women ≥70 years of age.15-17

The prevalence of alopecia also increases with age in men, affecting more than 80% of Caucasian men ≥70 years of age.15,18-21

The hair follicle is a unique organ in the body that undergoes cycles of

  • hair production (anagen)
  • apoptosis-mediated regression (catagen), and
  • relative quiescence (telogen).22

This cyclical process is complex and regulated by several factors, including sensory neurons.23 Sensory neurons release CGRP, which has been shown to be an important regulatory factor in hair growth.11

The proximal epithelium of anagen hair follicles are known to be an area of immune privilege.24 Immune privilege is characterized by a low level of expression of major histocompatibility complex (MHC) class I antigens. The function of MHC is to present antigens to T cells and if present on the hair bulb cells, they may facilitate damage to the hair follicle by the T cells.11

Immune privilege at the anagen hair follicles is generated and maintained by a number of mechanisms, including 

  • local production of immunosuppressive agents, and
  • decreased MHC expression.14

Calcitonin-gene related peptide might be an important regulatory factor for maintenance and restoration of immune privilege via suppression of MHC class I antigen, which in turn could protect proximal hair follicles from autoreactive cluster of differentiation 8 T-cell attack.14

Overview of Phase 3 Migraine Prevention Studies

Galcanezumab has been studied in phase 3, randomized, double-blind, placebo-controlled studies in adult patients for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2)1,2
  • chronic migraine (REGAIN),3 and
  • episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories (CONQUER).4

Patients were randomized to either placebo or treatment in a

  • 2:1:1 ratio in the EVOLVE-1, EVOLVE-2, REGAIN studies,1-3 and
  • 1:1 ratio in the CONQUER study.4

Summary of Study Design in the Migraine Prevention Studies Summarizes the galcanezumab doses used and duration of the migraine prevention studies.

Summary of Study Design in the Migraine Prevention Studiesa

 

GMB Doses Studied

Study Duration

EVOLVE-11
EVOLVE-22

120 mg monthlyb
or
240 mg monthly

6 months double-blind

REGAIN3,25

120 mg monthlyc
or
240 mg monthly

3 months double-blind,
with optional 9-month open-label extensiond

CONQUER4,26

120 mg monthlyb

3 months double-blind,
with optional 3-month open-label extensione

CGAJ27

120 mg monthlyb
or
240 mg monthly

12 months open-label

Abbreviations: GMB = galcanezumab; OLE = open-label extension.

aWith the exception of study CGAJ, all studies were randomized, double-blind, and placebo-controlled.

bThe initial dose was administered as a 240-mg loading dose, followed by subsequent monthly doses of 120 mg.

cThe initial dose was administered as a 240-mg loading dose, followed by subsequent monthly doses of 120 mg during double-blind treatment.

dThe dosing regimen for the OLE started all patients on a 240-mg galcanezumab loading dose (2 injections of 120 mg each) after completing double-blind treatment at month 3. At month 4, all patients then received a maintenance dose of 120 mg galcanezumab (single injection) in order to encourage the use of the lowest possible monthly maintenance dose. However, starting at month 5, dosing was flexible such that patients could receive 1 injection (120 mg) or 2 injections (a total of 240 mg) per month at the investigators’ clinical discretion.

eDosing in the OLE was 120 mg per month galcanezumab, with a blinded loading dose of 240 mg for previous-placebo patients. Thus, all patients received two injections at their first open-label dose visit (either two 120-mg galcanezumab injections or one 120-mg galcanezumab injection plus one placebo injection) and a single injection of galcanezumab 120 mg at all subsequent monthly dosing visits.

Overview of Phase 3 Cluster Headache Studies

Galcanezumab was studied in 2 phase 3, randomized, double-blind, placebo-controlled studies in adults with

  • episodic cluster headache (CGAL), and
  • chronic cluster headache (CGAM).5,6

The CGAM study in chronic cluster headache did not meet its primary endpoint.5 However, safety results from the 2 placebo-controlled cluster headache trials were integrated and are the primary analysis set used for evaluation of galcanezumab safety in cluster headache.8

Patients were randomized at the beginning of double-blind treatment in a 1:1 ratio to receive monthly subcutaneous doses of

  • placebo, or
  • galcanezumab 300 mg.5,6

Summary of Phase 3, Double-Blind, Placebo-Controlled Galcanezumab Cluster Headache Studies summarizes the galcanezumab doses used and duration of the cluster headache studies.

Summary of Phase 3, Double-Blind, Placebo-Controlled Galcanezumab Cluster Headache Studies

Study Acronym

Population

Treatments

Study Duration

CGAL6
N=106

Episodic cluster headache

GMB 300 mg or PBO monthly

2-month double-blind

CGAM5,7
N=237

Chronic cluster headache

GMB 300 mg or PBO monthly

3-month double-blind, with optional 12-month open-label extension

Abbreviations: GMB = galcanezumab; PBO = placebo.

Date of Last Review: March 18, 2025

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