Emgality® (Galcanezumab)

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Which cardiovascular side effects were seen in galcanezumab clinical trials?

Treatment with galcanezumab did not result in clinically important differences in treatment-emergent or serious cardiovascular adverse events compared to placebo.

MX_cFAQ_GLC105_X2_CV_TEAEs
MX_cFAQ_GLC105_X2_CV_TEAEs
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Analysis of Cardiovascular Adverse Events

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

The cardiovascular adverse event profile of galcanezumab was evaluated using integrated data from a total of 5 placebo-controlled studies with up to 6 months of galcanezumab exposure (with 573.4 patient-years of exposure).1

Galcanezumab doses were pooled prior to the analysis, as galcanezumab doses were different across studies.1

In these studies, the majority of patients were female (>75%) and Caucasian (>75%), with a mean age of 41 to 42 years.2

Cardiovascular safety definitions and search strategy used to identify likely cardiovascular treatment-emergent events in the clinical studies are discussed in the Appendix.

This integrated analysis found that the incidence of cardiovascular treatment-emergent adverse events and serious adverse events was low and did not differ between the galcanezumab and placebo groups.1 These findings were consistent with, and expand upon, an earlier analysis of cardiovascular safety based on data from 3 placebo-controlled studies.3

Low Frequency of Cardiovascular Adverse Events

The incidence of cardiovascular adverse events was low, and there were no significant differences between the galcanezumab and placebo groups in the frequency of cardiovascular

Likely Cardiovascular Treatment-Emergent Adverse Events:a Placebo-Controlled Group2

 

PBO
N=1628
n (%)

GMB Pooledb
N=1601
n (%)

Patients with ≥1 CV TEAE

53 (3.3)

50 (3.1)

Cardiac arrhythmias

6 (0.4)

7 (0.4)

Cardiac failure

1 (0.1)

0 (0.0)

Cardiomyopathy

0 (0.0)

0 (0.0)

CNS vascular disorders

0 (0.0)

1 (0.1)

Embolic and thrombotic events

4 (0.3)

4 (0.3)

Hypertension

21 (1.3)

19 (1.2)

Ischemic heart disease

1 (0.1)

2 (0.1)

Pulmonary hypertension

0 (0.0)

0 (0.0)

Torsades de pointes/QT prolongation

2 (0.1)

2 (0.1)

Abbreviations: CNS = central nervous system; CV = cardiovascular; GMB = galcanezumab; N = number of patients in the analysis population; n = number of patients within each specific category; PBO = placebo; TEAE = treatment-emergent adverse event.

aEach preferred term represents the narrow scope terms only.

bAll galcanezumab doses combined.

Likely Cardiovascular Serious Adverse Events:a Placebo-Controlled Group2

 

PBO
N=1628
n (%)

GMB Pooledb
N=1601
n (%)

Patients with ≥1 CV SAE

3 (0.2)

4 (0.3)

Myocardial infarction

1 (0.1)

1 (0.1)

Pulmonary embolism

1 (0.1)

1 (0.1)

Transient ischemic attack

0 (0.0)

1 (0.1)

Deep vein thrombosis

1 (0.1)

0 (0.0)

Atrial fibrillation

0 (0.0)

1 (0.1)

Abbreviations: CV = cardiovascular; GMB = galcanezumab; N = number of patients in the analysis population; n = number of patients within each specific category; PBO = placebo; SAE = serious adverse event.

aEach preferred term represents the narrow scope terms only.

bAll galcanezumab doses combined.

References

1Oakes T, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in patients treated with longer-term exposure to galcanezumab. Neurology. 2021;96(15 Suppl):2344. https://n.neurology.org/content/96/15_Supplement/2344

2Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular risks in patients treated with longer-term exposure to galcanezumab. Poster presented at: 73rd American Academy of Neurology Meeting (AAN Virtual); April 17-22, 2021. Accessed May 5, 2021. http://lillyscience.lilly.com/download/6b3qbWdDjwtIwA2UzahuEp?utm_source=email&scannedLink=true.

3Oakes TM, Kovacs R, Rosen N, et al. Evaluation of cardiovascular outcomes in adult patients with episodic or chronic migraine treated with galcanezumab: data from three phase 3, randomized, double-blind, placebo-controlled EVOLVE-1, EVOLVE-2, and REGAIN studies. Headache. 2020;60(1):110-123. http://dx.doi.org/10.1111/head.13684

4Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Appendix

Evaluation of Cardiovascular Safety - Definitions and Search Strategy

Potential treatment-emergent cardiovascular events were identified using the Medical Dictionary for Regulatory Activities (MedDRA) standard MedDRA queries (SMQ) listed below; only narrow term events are shown in the results. A listing of patients having a treatment-emergent adverse event potentially cardiovascular in nature was generated from these SMQs.4

Medical Dictionary for Regulatory Activities SMQ ‘narrow’ terms included preferred terms that are highly likely to represent the condition of interest.4

The SMQs analyzed to identify potential treatment-emergent cardiovascular events were3,4

  • Cardiac arrhythmias (includes sub-SMQs; SMQ 20000049)
  • Cardiac failure (SMQ 20000004)
  • Cardiomyopathy (SMQ 20000150)
  • Central nervous system vascular disorders (includes sub-SMQs; SMQ 20000060)
  • Embolic and thrombotic events (includes sub-SMQs; SMQ 20000081)
  • Hypertension (SMQ 20000147)
  • Ischemic heart disease (includes sub-SMQs; SMQ 20000043)
  • Pulmonary hypertension (SMQ 20000130), and
  • Torsades de pointes/QT prolongation (SMQ 20000001).

The list of potential cardiovascular treatment-emergent adverse events identified by these preferred terms was then medically reviewed to determine if the terms identified represented likely cardiovascular treatment-emergent adverse events. The medical review was conducted by an Eli Lilly and Company physician with clinical trial medical data review experience who was blinded to study treatment. Only those events that were judged medically to represent likely cardiovascular treatment-emergent adverse events are discussed herein unless otherwise specified.3,4

Fecha de la última revisión: 2021 M05 04


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