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Discover what Emgality® can do for patients with episodic migraine1

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For your patients with 4 to 14 MHDs per month1

Emgality delivered significantly more migraine-free days vs placebo1

Emgality prevented significantly more mean monthly MHDs vs placebo1a:

  • EVOLVE-1: 4.7 with Emgality 120 mg (N=210) vs 2.8 with placebo (N=425) (baseline mean: 9.2 vs 9.1) over Months 1 to 6 (p<0.001)
  • EVOLVE-2: 4.3 with Emgality 120 mg (N=226) vs 2.3 with placebo (N=450) (baseline mean: 9.1 vs 9.2) over Months 1 to 6 (p<0.001)

Emgality reduced mean monthly MHDs1

Mean Change From Baseline in Monthly MHDs1,2a

Chart of mean change from baseline in monthly MHD for EVOLVE-1
Chart of mean change from baseline in monthly MHD for EVOLVE-2

aLS means and 95% confidence intervals are presented.1,2,4

bEarliest post-baseline, prespecified assessment.

No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month. However, patients treated with Emgality 120 mg showed a nominally greater reduction in number of monthly MHDs at each month compared to placebo.1,2

See MHD data for chronic migraine .

See study design for EVOLVE-1 and EVOLVE-2 .

SELECT IMPORTANT SAFETY INFORMATION

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.

For your patients with 4 to 14 MHDs per month1

Emgality is the first and only CGRP antagonist antibody that evaluated and demonstrated significance vs placebo in 100% response rates in two phase 3 trials1,5-9

Mean Percentage of Patients Meeting Defined Levels of Reduction in Monthly MHDs Over Months 1 to 61

MHD Response rates for EVOLVE-1 and EVOLVE-2

cp<0.001 vs placebo.1

CGRP=calcitonin gene-related peptide; LS=least-square; MHD=migraine headache day.

In REGAIN, Emgality 120 mg was not significantly better than placebo for the mean percentage of patients with ≥75% or 100% reduction from baseline in the number of monthly MHDs over the 3-month treatment period.1

See study design for REGAIN .

See MHD response rate data for chronic migraine .

SELECT IMPORTANT SAFETY INFORMATION

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. Emgality. Prescribing Information. Lilly USA, LLC.
  2. Data on File. Lilly USA, LLC. DOF-GZ-US-0002.
  3. 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.
  4. Data on File. Lilly USA, LLC. DOF-GZ-US-0120.
  5. 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.
  6. 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.
  7. Aimovig. Prescribing Information. Amgen Inc.
  8. Ajovy. Prescribing Information. Teva Pharmaceuticals USA, Inc.
  9. Vyepti. Prescribing Information. Lundbeck Seattle BioPharmaceuticals, Inc.

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