Emgality® (Galcanezumab)

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Are there any long-term cardiovascular effects with galcanezumab?

The incidence of treatment-emergent or serious cardiovascular adverse events did not increase with longer treatment duration, with up to 1799 patient-years of exposure to galcanezumab.

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Analysis of Long-Term 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 9 galcanezumab phase 2 or phase 3 placebo-controlled and open-label studies, up to 12 months in duration.1

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

These studies were analyzed into 2 groups with the

  • placebo-controlled group composed of 5 placebo-controlled studies with up to 6 months of galcanezumab exposure (with 573.4 patient-years of exposure), and
  • all-galcanezumab group composed of all 9 galcanezumab studies (with 1799.4 patient-years of exposure).1

Longer-term exposure to galcanezumab was evaluated using the all-galcanezumab group.2

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 treatment-emergent and serious cardiovascular adverse events with galcanezumab

  • were low, and
  • did not increase with longer term exposure, as compared with the double-blind, placebo-controlled group.1

These findings are consistent with, and expand upon, an earlier analysis of cardiovascular safety based on data from 3 placebo-controlled studies of up to 6 months in duration.3

Cardiovascular Events Not Affected by Longer Treatment Duration

The frequency of cardiovascular treatment-emergent or serious adverse events did not increase with longer term exposure (Cardiovascular Treatment-Emergent and Serious Adverse Events With Longer Term Exposure), which is represented by the all-galcanezumab group.1

Cardiovascular Treatment-Emergent and Serious Adverse Events With Longer Term Exposure2

 

All-GMB Group
n (%)

PBO
n (%)

GMB Pooleda
n (%)


Placebo-Controlled Group

TEAEb

N=2882

N=1628

N=1601

Patients with ≥1 CV TEAE

142 (4.9)

53 (3.3)

50 (3.1)

Cardiac arrhythmias

22 (0.8)

6 (0.4)

7 (0.4)

Cardiac failure

1 (0.0)

1 (0.1)

0 (0.0)

CNS vascular disorders

4 (0.1)

0 (0.0)

1 (0.1)

Embolic and thrombotic events

8 (0.3)

4 (0.3)

1 (0.1)

Hypertension

49 (1.7)

21 (1.3)

19 (1.2)

Ischemic heart disease

3 (0.1)

1 (0.1)

2 (0.1)

Torsades de pointes/QT prolongation

5 (0.2)

2 (0.1)

2 (0.1)

SAEb

N=2889

N=1628

N=1601

Patients with ≥1 CV SAE

8 (0.3)c

3 (0.2)

4 (0.3)

Myocardial infarction

2 (0.1)

1 (0.1)

1 (0.1)

Pulmonary embolism

1 (0.0)

1 (0.1)

1 (0.1)

Transient ischemic attack

1 (0.0)

0 (0.0)

1 (0.1)

Deep vein thrombosis

0 (0.0)

1 (0.1)

0 (0.0)

Atrial fibrillation

1 (0.0)

0 (0.0)

1 (0.1)

Cerebral ischemia

1 (0.0)

0 (0.0)

0 (0.0)

Palpitation

1 (0.0)

0 (0.0)

0 (0.0)

Angina unstable

1 (0.0)

0 (0.0)

0 (0.0)

Cardiac failure congestive

1 (0.0)

0 (0.0)

0 (0.0)

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; SAE = serious adverse event; TEAE = treatment-emergent adverse event.

aAll galcanezumab doses combined.

bEach preferred term represents the narrow scope terms only.

cOne event each of myocardial infarction and unstable angina occurred in the same patient.

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: May 05, 2021


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