Emgality® (Galcanezumab)

Para consultar la información para prescribir completa de Emgality® (Galcanezumab) de clic en el siguiente enlace: Información para prescribir

La información es proporcionada en respuesta a su solicitud, y puede contener datos relacionados a dosis, usos, formulaciones y poblaciones diferentes a la Información para Prescribir del producto. Consulte la Información para Prescribir en la liga que aparece arriba.

Galcanezumab: Comparison With Other CGRP Monoclonal Antibodies

There are no head-to-head studies comparing galcanezumab and other CGRP antibodies in the prevention of migraine. Limited real-world setting data are becoming available.

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The information contained in this letter may not completely match the current local labeling for GALCANEZUMAB. Please see local labeling approved in your country.

Lack of Head-to-Head Comparison Studies

Due to the lack of head-to-head studies comparing galcanezumab with other CGRP antibodies for migraine prevention, it is unknown whether there are differences in the safety and efficacy profiles of these therapeutic antibodies.

Between the various CGRP therapeutic antibodies, there may be differences in the

  • molecular target (ligand or receptor)
  • IgG subclass
  • route of administration
  • PK profile
  • dosing frequency, and
  • AE profile.1-5

Please contact the manufacturer(s) of the other CGRP therapeutic antibodies for information regarding those products.

Limited real-world data comparing other CGRP mAbs to galcanezumab are becoming available and are summarized below.

Galcanezumab Clinical Characteristics

Galcanezumab is a humanized IgG4 mAb that binds CGRP and prevents its biological activity without blocking the CGRP receptor.6

Galcanezumab is indicated for the prophylaxis of migraine in adults.6

The recommended migraine dose is 120 mg injected subcutaneously once monthly, with a 240-mg loading dose as the initial dose.6

Based on a population PK analysis, the CL/F of galcanezumab was approximately 0.008 L/h and the t1/2 of galcanezumab was 27 days.6

Published Literature Comparing CGRP mAbs in the Real-World Setting

There are currently 4 CGRP mAbs approved for the prevention of migraine. These include

  • eptinezumab
  • erenumab
  • fremanezumab, and
  • galcanezumab.

Efficacy of CGRP mAbs

Although there are no direct comparative trials, the available published literature suggests that in both episodic and chronic migraine,1-3 efficacy for CGRP mAbs is similar in the reduction of

  • monthly migraine headache days1-3,7
  • acute medication use1,3,5,7, and
  • migraine-related disability.1

Safety of CGRP mAbs

In clinical trials, CGRP mAbs demonstrated a good safety and tolerability profile.3

Neither cardiovascular nor immunological safety concerns have emerged from CGRP mAb clinical trials.1,3

The incidence of AEs was similar overall between the CGRP mAbs compared to placebo.2

Other Conclusions

Conclusions from available published literature indicate treatment with CGRP mAbs may be beneficial for patients who

  • have failed previous preventive treatment, or
  • have been intolerant to preventive treatment based on comorbidities.1,5

However, additional real-world data are needed to determine any differences in safety of the various CGRP mAbs with long-term use.1

References

1Negro A, Martelletti P. Patient selection for migraine preventive treatment with anti-CGRP(r) monoclonal antibodies. Expert Rev Neurother. 2019;19(8):769-776. https://doi.org/10.1080/14737175.2019.1621749

2Schoenen J, Manise M, Nonis R, et al. Monoclonal antibodies blocking CGRP transmission: an update on their added value in migraine prevention. Rev Neurol. 2020;176(10):788-803. https://doi.org/10.1016/j.neurol.2020.04.027

3Raffaelli B, Neeb L, Reuter U. Monoclonal antibodies for the prevention of migraine. Expert Opin Biol Ther. 2019;19(12):1307-1317. https://doi.org/10.1080/14712598.2019.1671350

4Ahmed Z, Hogue O, Lee M, et al. Calcitonin gene related peptide monoclonal antibodies in the treatment of migraine: is there a difference in efficacy between inhibitors of the ligand compared to inhibitors of the receptor? Headache. 2020;60(S1):4. 62nd Annual Scientific Meeting American Headache Society abstract. https://doi.org/10.1111/head.13854

5Dodick DW. CGRP ligand and receptor monoclonal antibodies for migraine prevention: evidence review and clinical implications. Cephalalgia. 2019;39(3):445-458. https://doi.org/10.1177/0333102418821662

6Data on file, Eli Lilly and Company and/or one of its subsidiaries.

7Zhu Y, Liu Y, Zhao J, et al. The efficacy and safety of calcitonin gene-related peptide monoclonal antibody for episodic migraine: a meta-analysis. Neurol Sci. 2018;39(12):2097–2106. https://doi.org/10.1007/s10072-018-3547-3

Glossary

AE = adverse event

CGRP = calcitonin gene-related peptide

CL/F = apparent clearance

IgG = immunoglobulin G

IgG4 = immunoglobulin G (subclass) 4

mAb = monoclonal antibody

PK = pharmacokinetics

t1/2 = elimination half-life

Fecha de la última revisión: 2021 M02 23


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