Emgality® (Galcanezumab)

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Galcanezumab: Effect on CGRP Levels

Total plasma CGRP levels increased after galcanezumab administration indicating CGRP binds to galcanezumab, reducing free CGRP.

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Detailed Information

CGRP Plasma Concentration

A drug-tolerant CGRP assay was used in the clinical program for migraine prevention and treatment of episodic cluster headache to measure total CGRP concentrations (total CGRP = galcanezumab-bound CGRP + free CGRP).1,2

When galcanezumab is administered, the premise is that

  • CGRP will bind to galcanezumab, and
  • the amount of free CGRP that is available to interact with the CGRP receptors will be reduced.1,2

Upon galcanezumab administration, galcanezumab-bound CGRP is expected to take on the disposition characteristics of galcanezumab resulting in

  • a lower clearance than free CGRP, and
  • an increase in total CGRP concentration.1,2

In the phase 3 double-blind, placebo-controlled migraine prevention and episodic cluster headache studies,3-6 total CGRP concentrations increased after galcanezumab administration compared to placebo. This indicated that the antibody was

Higher total CGRP concentrations in galcanezumab-treated patients were associated with a greater change from baseline compared to placebo in reduction of

  • monthly migraine headache days for patients with episodic or chronic migraine,2 and
  • episodic cluster headache attack frequency.1
Total CGRP Plasma Mean Concentrations (ng/mL) at End of Double-Blind Treatment in the Phase 3 Migraine Prevention Studies1

 

PBO

GMB 120 mg

GMB 240 mg

EVOLVE-1a

0.89

4.25

5.13

EVOLVE-2a

0.54

3.93

4.98

REGAINb

0.53

4.02

4.85

Abbreviations: CGRP = calcitonin gene-related peptide; GMB = galcanezumab; PBO = placebo.

aRepresents total CGRP plasma concentrations at month 6.

bRepresents total CGRP plasma concentrations at month 3.

Total CGRP Plasma Mean Concentrations (ng/mL) at End of Double-Blind Treatment in the Episodic Cluster Headache Study1

 

PBO

GMB 300 mg

CGALa

0.327

4.60

Abbreviations: CGRP = calcitonin gene-related peptide; GMB = galcanezumab; PBO = placebo.

aRepresents total plasma CGRP concentrations at month 2.

References

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

2Kielbasa W, Helton DL. A new era for migraine: Pharmacokinetic and pharmacodynamic insights into monoclonal antibodies with a focus on galcanezumab, an anti-CGRP antibody. Cephalalgia.2019;39(10):1284-1297. http://dx.doi.org/10.1177/0333102419840780

3Stauffer 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

4Skljarevski 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

5Detke 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

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

Glossary

CGRP = calcitonin gene-related peptide

Fecha de la última revisión: 2020 M02 06


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