Emgality® (Galcanezumab)

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Galcanezumab: Migraine Headache Prevention - Phase 3 Results

Patients treated with galcanezumab had significantly greater decreases in monthly migraine headache days compared to patients treated with placebo. Injection site reactions, including pain, were the most commonly reported adverse events.

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Phase 3 Migraine Prevention Program

The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country. If you require the local labeling, please request it through your Sales Representative.

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

Galcanezumab has also been studied in a phase 3, open-label, 12-month safety study (CGAJ) for the prevention of episodic or chronic migraine.5

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

Summary of Study Design in the Migraine Prevention Studiesa

 

GMB Doses Studied

Study Duration

EVOLVE Studies1,2

120 mg monthlyb
or
240 mg monthly

6 months double-blind

REGAIN3

120 mg monthlyb
or
240 mg monthly

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

CONQUER4

120 mg monthlyb

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

CGAJ5

120 mg monthlyb
or
240 mg monthly

12 months open-label

Abbreviation: GMB = galcanezumab.

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.

The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days over

  • 6 months for the EVOLVE-1 and EVOLVE-2 studies,1,2 and
  • 3 months for the REGAIN and CONQUER studies.3,4

In the 12-month, open-label, safety study, the primary endpoint was the long-term safety and tolerability of galcanezumab for up to 12 months of treatment.5

Key Efficacy Results

Galcanezumab met the primary endpoint in the double-blind, placebo controlled phase 3 studies of galcanezumab for the prevention of episodic and chronic migraine.1-4 

In these studies, patients treated with galcanezumab experienced a significantly greater decrease in the number of monthly migraine headache days compared to patients treated with placebo over 

  • the 6-month double-blind treatment period in the EVOLVE studies,1,2and
  • the 3-month double-blind treatment period in the REGAIN and CONQUER studies.3,4 

These results are summarized in Overall Mean Change From Baseline in Monthly Migraine Headache Days.

Overall Mean Change From Baseline in Monthly Migraine Headache Days

Study

Galcanezumab
120 mg

Galcanezumab
240 mg

Placebo

EVOLVE-11a

– 4.7 daysb

 4.6 daysb

 2.8 days

EVOLVE-22a

 4.3 daysb

 4.2 daysb

 2.3 days

REGAIN3c

 4.8 daysb

 4.6 daysb

 2.7 days

CONQUER4d

− 4.1 dayse

N/A

− 1.0 days

Abbreviation: N/A = not applicable.

aMonths 1 to 6; episodic migraine.

bp<.001 vs placebo.

cMonths 1 to 3; chronic migraine.

dMonths 1 to 3; episodic or chronic migraine that has not benefited from 2 to 4 previous migraine prevention medication categories.

ep<.0001 vs placebo.

In the double-blind, placebo-controlled studies, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several prespecified secondary endpoints, including response rates and measures of daily activities.1-4

Efficacy measures were a secondary objective in the 12-month, open-label safety study.5 In study CGAJ, the overall reduction in monthly migraine headache days over 12 months was 5.6 days for galcanezumab 120 mg and 6.5 days for galcanezumab 240 mg. The reduction in monthly migraine headache days was evident at month 1 and was maintained throughout the treatment period. This study was not blinded nor placebo-controlled, and results should be interpreted with these factors in mind.

Key Safety Results

The EVOLVE-1, EVOLVE-2, and REGAIN studies were the pivotal studies and safety results have been integrated resulting in a pooled analysis of 2886 adult patients, comprised of a total of 1435 patients that received monthly doses of galcanezumab (120 mg or 240 mg) administered subcutaneously.6

The most commonly reported TEAEs in the integrated safety analysis were injection site reactions, including pain (Common TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment: Migraine Prevention).6 Constipation, pruritis (not associated with injection site) and vertigo were also considered to be adverse events associated with galcanezumab treatment.

Commona TEAEs Reported ≥2% Among Galcanezumab-Treated Patients During Phase 3 Double-Blind Treatment: Migraine Prevention6,7

TEAEb

PBO
N=1451
n (%)

GMB 120 mg
N=705
n (%)

GMB 240mg
N=730
n (%)

GMB Pooled
N=1435
n (%)

Injection site pain

138 (9.5)

71 (10.1)

85 (11.6)

156 (10.9)

Nasopharyngitis

94 (6.5)

52 (7.4)

31 (4.3)c

83 (5.8)

URTI

60 (4.1)

31 (4.4)

36 (4.9)

67 (4.7)

Injection site reaction

14 (1.0)

22 (3.1)d

45 (6.2)d

67 (4.7)d

Dizziness

41 (2.8)

20 (2.8)

20 (2.7)

40 (2.8)

Injection site erythema

20 (1.4)

20 (2.8)c

29 (4.0)d

49 (3.4)d

Sinusitis

31 (2.1)

20 (2.8)

19 (2.6)

39 (2.7)

UTI

33 (2.3)

19 (2.7)

18 (2.5)

37 (2.6)

Fatigue

34 (2.3)

17 (2.4)

16 (2.2)

33 (2.3)

Injection site pruritis

2 (0.1)

15 (2.1)d

24 (3.3)d

39 (2.7)d

Neck pain

21 (1.5)

15 (2.1)

6 (0.8)

21 (1.5)

Abdominal pain

24 (1.7)

13 (1.8)

6 (0.8)

19 (1.3)

Cough

19 (1.3)

12 (1.7)

13 (1.8)

25 (1.7)

Oropharyngeal pain

13 (0.9)

10 (1.4)

12 (1.6)

22 (1.5)

Bronchitis

17 (1.2)

9 (1.3)

11 (1.5)

20 (1.4)

Influenza

34 (2.3)

8 (1.1)

20 (2.7)

28 (2.0)

Constipation

8 (0.6)

7 (1.0)

11 (1.5)c

18 (1.3)c

Migraine

14 (1.0)

7 (1.0)

12 (1.6)

19 (1.3)

Abbreviations: GMB = galcanezumab; MedDRA = Medical Dictionary for Regulatory Activities; PBO = placebo; TEAE = treatment-emergent adverse event; URTI = upper respiratory tract infection; UTI = urinary tract infection.

a≥2% after rounding (at least 1.5% before rounding) in any galcanezumab-treated group and greater than placebo.

bMedDRA version 19.1 was used.

cp<.05 vs placebo.

dp<.001 vs placebo.

The CONQUER study was not included in the integrated safety analysis. While the safety profile in the CONQUER study was consistent with the established safety profile of galcanezumab, the most commonly reported TEAE  in this study was nasopharyngitis.4

Study CGAJ was used to evaluate longer term safety, which showed that the incidence rates for TEAE adjusted for exposure did not increase with longer treatment duration.6

References

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

5Camporeale 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

6Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020;20(1):25. https://doi.org/10.1186/s12883-020-1609-7

7Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

TEAE = treatment-emergent adverse event

Fecha de la última revisión: 2020 M08 28


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