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In a study of patients with episodic and chronic migraine who experienced 2-4 prior preventive category failures,1

Emgality delivered significant reductions in MHDs1

CONQUER: -4.1 days on Emgality 120 mg (n=232) vs -1.0 day on placebo (n=230) over Months 1 to 3 (baseline: 13.4 vs 13.0) (p<0.0001)1a

aLS means are present.

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Contraindications

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

EMGALITY SIGNIFICANTLY REDUCED THE BURDEN OF MIGRAINE IN BETWEEN ATTACKS2

Patients taking Emgality reported improvement in the burden of migraine in between attacks, as assessed by the MIBS-4.2

Mean change from baseline on the MIBS-4 was greater for patients treated with Emgality vs placebo.

Mean Reduction From Baseline in MIBS-4 at Month 32a

Chart showing mean change from baseline in MIBS-4 score at Month 3 in CONQUER

aLS means are presented.2
bNominal p-value ≤0.001 vs placebo.2

Statistical significance does not imply clinically meaningful difference.

Change in MIBS-4 from baseline to Month 3 was evaluated using an ANCOVA model controlling for prespecified effects. For missing MIBS-4 score at Month 3 (9 in placebo, 8 in Emgality 120 mg) LOCF was used. There was no adjustment for multiplicity in the treatment comparisons using the MIBS-4.2

MIBS-4 measures the burden of migraine between attacks, including disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty.3-5

  • MIBS-4 is scored on a scale from 0 to 12. A score of 0 indicates no burden, 1-2 indicates mild burden, 3-4 indicates moderate burden, and scores ≥5 indicate severe burden

ANCOVA=analysis of covariance; LOCF=last observation carried forward; MHD=migraine headache day; MIBS-4=Migraine Interictal Burden Scale-4.

See study designs for CONQUER.

See MSQ v2.1 RF-R data.

See MIBS-4 Questionnaire.

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Raynaud's Phenomenon

Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Emgality. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

Emgality should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

References

  1. Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19(10):814-825.
  2. García-Azorin D, Ford J, Buse DC, et al. Changes in work productivity and interictal burden: results from randomized, double-blind study evaluating galcanezumab in adults with treatment resistant migraine (CONQUER). Presented at: 17th Asian Oceanian Congress of Neurology (AOCN 2021); Taipei, Taiwan; April 1-4, 2021.
  3. Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84(5):422-435.
  4. Buse DC, Bigal M, Rupnow M, et al. Development and validation of the Migraine Interictal Burden Scale (MIBS): a self-administered instrument for measuring the burden of migraine between attacks [abstract S05.003]. Neurology. 2007;68(suppl 1):A89.
  5. Buse DC, Bigal M, Rupnow M, et al. The migraine interictal burden scale (MIBS): results of a population-based validation study. Headache. 2007;47(5):778.

IMPORTANT SAFETY INFORMATION

Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.

Hypertension
Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Emgality, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation. Emgality was discontinued in many of the reported cases.

Monitor patients treated with Emgality for new-onset hypertension or worsening of pre-existing hypertension, and consider whether discontinuation of Emgality is warranted if evaluation fails to establish an alternative etiology or blood pressure is inadequately controlled.

Raynaud’s Phenomenon
Development of Raynaud’s phenomenon and recurrence or worsening of pre-existing Raynaud’s phenomenon have been reported in the postmarketing setting following the use of CGRP antagonists, including Emgality. In reported cases with monoclonal antibody CGRP antagonists, symptom onset occurred after a median of 71 days following dosing. Many of the cases reported serious outcomes, including hospitalizations and disability, generally related to debilitating pain. In most reported cases, discontinuation of the CGRP antagonist resulted in resolution of symptoms.

Emgality should be discontinued if signs or symptoms of Raynaud’s phenomenon develop, and patients should be evaluated by a healthcare provider if symptoms do not resolve. Patients with a history of Raynaud’s phenomenon should be monitored for, and informed about the possibility of, worsening or recurrence of signs and symptoms.

The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.

Emgality is an injectable prescription medicine, available as:

  • prefilled single-dose pen with 120 mg/mL solution
  • prefilled single-dose syringe with 120 mg/mL solution
  • prefilled single-dose syringe with 100 mg/mL solution

Please see Full Prescribing Information for Emgality. See Instructions for Use included with the device.

GZ HCP ISI 04APR2025

INDICATIONS

Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the:

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache