Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Jämförelse med andra monoklonala CGRP antikroppar

Det finns inga direkt jämförande studier som jämför galcanezumab och andra CGRP-antikroppar för att förebygga migrän.

Additional Information

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.

There may be differences in molecular target (ligand or receptor), IgG subclass, route of administration, PK profile, or dosing frequency between the various CGRP therapeutic antibodies.

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

Galcanezumab Clinical Characteristics

Galcanezumab is a humanized IgG4 mAb that

  • binds CGRP, thus

  • preventing its biological activity.1

The half life of galcanezumab was 27 days.1

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

A high-level summary of the galcanezumab phase 3 migraine prevention program are provided below.

Phase 3 Migraine Prevention Program

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),2,3 and

  • chronic migraine (REGAIN).4

Galcanezumab met the primary endpoint in the phase 3 studies of galcanezumab for the prevention of episodic and chronic migraine.2-4

Key Efficacy Results

The primary endpoint was the overall mean change from baseline in the number of monthly MHDs over

  • 6 months for episodic migraine, and

  • 3 months for chronic migraine.2-4

In all 3 studies, patients treated with galcanezumab 120 mg and 240 mg doses experienced a significantly greater decrease in the number of monthly MHDs compared to patients treated with placebo over 

  • the 6-month double-blind treatment period for episodic migraine, and

  • the 3-month double-blind treatment period for chronic migraine (Table 1).2-4

  • The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1 Please note that the results of a maintenance dose of 240 mg galcanezumab once monthly are also included in this response. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

Table 1. Overall Mean Change From Baseline in Monthly Migraine Headache Days

Study

Galcanezumab
120 mg

Galcanezumab
240 mg

Placebo

EVOLVE-12a

4.7 daysb

– 4.6 daysb

– 2.8 days

EVOLVE-23a

– 4.3 daysb

– 4.2 daysb

– 2.3 days

REGAIN4c

– 4.8 daysb

– 4.6 daysb

– 2.7 days

a Months 1 to 6.

b p<.001 vs placebo.

c Months 1 to 3.

Note: The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose .1 The results of a maintenance dose of galcanezumab 240 mg once monthly are also described here. Even though this dose has been tested in pivotal studies, it has not been approved and therefore is not recommended.

In all 3 studies, patients treated with galcanezumab experienced statistically significant improvement compared to placebo on several pre-specified secondary endpoints, including response rates and measures of daily activities.2-4

Key Safety Results

The most commonly reported treatment-emergent adverse events were injection site reactions, including pain. The observed safety and tolerability profile was consistent with findings from previous studies of galcanezumab.2-4

The reported adverse drug reactions for 120 mg and 240 mg were

  • injection site pain (10.1 %/11.6 %),

  • injection site reactions (9.9 %/14.5 %),

  • vertigo (0.7 %/1.2 %),

  • constipation (1.0 %/1.5 %),

  • pruritus (0.7 %/1.2 %) and

  • urticaria (0.3 %/0.1 %).1

Most of the reactions were mild or moderate in severity. Less than 2.5 % of patients in these studies discontinued due to adverse events.1

Therapeutic Indication

Galcanezumab is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.1

The recommended dose is 120 mg galcanezumab injected subcutaneously once monthly, with a 240 mg loading dose as the initial dose.1

References

1. Emgality [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Stauffer 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

3. Skljarevski 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

4. Detke 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

Glossary

CGRP = calcitonin gene-related peptide

IgG4 = immunoglobulin G (subclass) 4

MHD = migraine headache day

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Datum fӧr senaste ӧversyn 2018 M02 27

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