Emgality® (Galcanezumab)

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Galcanezumab: Efficacy by Body Weight

The efficacy of galcanezumab was not analyzed by body weight subgroups. No dose adjustment is needed on the basis of weight.

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Detailed Information

This medical response may not completely match the information in the current local labeling for GALCANEZUMAB. Please see local labeling for approved label information.

No Dose Adjustment is Needed on the Basis of Weight

No dose adjustment is needed on the basis of weight as there was no clinically meaningful effect on the CL/F or V/F of galcanezumab.1

Based on population PK analyses in healthy subjects and patients with migraine where the body weight of patients ranged from 37.1 to 141.3 kg (81.6 to 310.9 lb), body weight was identified as the only statistically significant covariate on CL/F affecting the PK of galcanezumab, with a less than proportional increase in CL/F with increasing body weight. However, in the context of PK variability, it was concluded that

  • no dose adjustment is needed on the basis of weight, and
  • patients at the 5th (52 kg [114.4 lb]) and 95th (105 kg [231 lb]) percentiles of body weight would not be expected to have different efficacy profiles.1

The same conclusions were further supported by population PK analyses in patients with episodic cluster headache.1

Baseline Weight and Body Mass Index in Clinical Pharmacology Studies

The galcanezumab clinical pharmacology studies included 446 healthy subjects, of whom 419 received at least one dose of galcanezumab (1 to 600 mg). Baseline body weight and BMI for subjects in those studies are provided in Baseline Weight and Body Mass Index in Galcanezumab Clinical Pharmacology Studies.1

Baseline Weight and Body Mass Index in Galcanezumab Clinical Pharmacology Studies1

Weight
kg (lb)

Body Mass Index
kg/m2

Mean

78.31 (172.28)

26.86

SD

14.42 (31.72)

4.11

Median

78.45 (172.59)

26.54

Minimum - Maximum

40.7 - 119.0 (89.54 - 261.8)

18.3 - 35.0

Galcanezumab Administration in Patients With Low or High Body Mass Index

Galcanezumab may be injected subcutaneously in the abdomen, thigh, back of the upper arm, and buttocks.1

The pre-attached needle in the autoinjector syringe and the prefilled syringe is 27 gauge and 0.5 inch long.1 The needle injection depth is

  • approximately 5.5 mm (0.25 inch) on the autoinjector syringe, and
  • controlled by user technique for the prefilled syringe.1

The baseline BMI measurements in patients from the phase 3 double-blind, placebo-controlled migraine prevention and cluster headache clinical trials were consistent with those observed in the clinical pharmacology studies: Baseline Mean Body Mass Index in Phase 3 Double-Blind, Placebo-Controlled Clinical Trials: Migraine and Cluster Headache .1

Baseline Mean Body Mass Index in Phase 3 Double-Blind, Placebo-Controlled Clinical Trials: Migraine and Cluster Headache1 

Population

N

Mean Body Mass Index (kg/m2)
(SD)

Migraine Prevention2-4

PBO

1450

27.33 (5.54)

GMB 120 mg

704

27.00 (5.36)

GMB 240 mg

730

27.34 (5.54)

Cluster Headache5

PBO

177

26.55 (4.88)

GMB 300 mg

176

26.35 (4.62)

Abbreviations: GMB = galcanezumab; PBO = placebo.

References

1Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2Detke 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

3Skljarevski 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

4Stauffer 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

5Goadsby 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

Glossary

BMI = body mass index

CL/F = apparent clearance

PK = pharmacokinetics

V/F = apparent volume of distribution

Fecha de la última revisión: 2019 M02 18


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