Emgality ® (galkanezumab)

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Emgality® ▼ (galcanezumab): Allmän säkerhet

Galcanezumab visade en gynnsam säkerhets- och tolerabilitetsprofil i fas 3-migränförebyggande studier.

Detailed Information

Description of Pooled Analysis and Summary of Exposure

Over 2500 patients were exposed to galcanezumab in clinical studies in migraine prophylaxis.

  • Over 1400 patients were exposed to galcanezumab during the double-blind treatment phase of the placebo-controlled phase 3 studies.

  • 279  patients were exposed for 12 months.1

The results are focused primarily on the findings from a pooled analysis of phase 3 double-blind, placebo-controlled studies for the prevention of

  • episodic migraine (EVOLVE-1 and EVOLVE-2),2,3 and

  • chronic migraine (REGAIN).4

This pooled analysis of 2886 adult patients included a total of 1435 patients that received galcanezumab (120 mg or 240 mg) subcutaneously.5

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.

The majority of patients were female (>80%) and Caucasian (>75%), with a mean age of 41-42 years.5

Overview of Adverse Events

Adverse events from EVOLVE-1, EVOLVE-2, and REGAIN are provided in the following table: Table 1.5,6 

Table 1. Overview of AEs Reported During Phase 3 Double-Blind Treatment5,6

Event

PBO
N=1451
n (%)

GMB 120 mg
N=705
n (%)

GMB 240 mg
N=730
n (%)

GMB Pooled
N=1435
n (%)

Deaths

0 (0.00)

0 (0.00)

0 (0.00)

0 (0.00)

SAEs

14 (1.0)

12 (1.7)

11 (1.5)

23 (1.6)

Discontinuation due to AE

24 (1.7)

13 (1.8)

22 (3.0)a

35 (2.4)

TEAEs

827 (57.0)

441 (62.6)a

472 (64.7)b

913 (63.6)b

Abbreviations: AE = adverse event; GMB = galcanezumab; PBO =  placebo; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

a p<.05 vs placebo.

b p<.001 vs placebo.

Note: The recommended dose for the prophylaxis of migraine in adults who have at least 4 migraine days per month 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.

List of adverse reactions

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

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

5. Stauffer VL, Wang S, Bangs M, et al. Phase 3 safety data from studies comparing galcanezumab and placebo in patients with episodic and chronic migraine. Poster presented at: European Academy of Neurology (EAN) – 4th Congress; June 16-19, 2018; Lisbon, Portugal.

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

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 2020 M02 07

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