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Emgality Walrus and Jessica Campaign image. For your patients with episodic migraine (4-14 migraine headache days [MHDs] per month), one of these is possible with Emgality<sup>®</sup>. The walrus that went to the moon. The woman who experienced a month of total migraine headache freedom. Emgality can give some patients the chance to be totally migraine-free for a month.<sup>1</sup>

For your patients with 4-14 MHDs per month (EVOLVE-1/EVOLVE-2),

Emgality demonstrated ≥50%, ≥75%, and 100% reductions in the number of monthly MHDs from baseline for a significantly greater mean percentage of patients vs placebo1

Mean percentage of patients meeting defined levels of reduction in monthly MHDs<sup>1</sup>

ap<0.001 vs placebo.

In the REGAIN study, in patients with chronic migraine (≥15 headache days per month), the mean percentage of patients achieving a ≥75% and 100% reduction in monthly MHDs from baseline was not significant vs placebo over Months 1 to 3.1

See study design for EVOLVE-1 and EVOLVE-2

See study design for REGAIN

INDICATION
Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated for the preventive treatment of migraine in adults.

SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.

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Reference: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.

Indications and Important Safety Information
Indications

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

  • Preventive treatment of migraine
  • Treatment of episodic cluster headache

Important Safety Information

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


WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
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.


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


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


GZ HCP ISI 10DEC2019

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Design: The approval of Emgality is based on the results of three Phase 3, randomized, multicenter, double-blind, placebo-controlled studies in adult patients (N=2886). EVOLVE-1 and EVOLVE-2 were 6-month trials that enrolled 1773 patients with episodic migraine (defined as 4 to 14 MHDs per month). REGAIN was a 3-month trial, followed by a 9-month open-label extension period, that enrolled 1113 patients with chronic migraine (defined as ≥15 headache days per month, of which at least 8 had the features of migraine).1,2,3,4

Endpoints: In all 3 studies, the primary endpoint was the overall mean change from baseline in the number of monthly MHDs, and key secondary endpoints included response rates (the mean percentages of patients with ≥50%, ≥75%, and 100% reduction from baseline in monthly MHDs), the mean change from baseline in patient functioning as assessed by the Role Function-Restrictive domain of the MSQ v2.1 across Months 4 to 6 for EVOLVE-1 and EVOLVE-2, and at Month 3 for REGAIN, and the overall mean change from baseline in the number of monthly MHDs that acute migraine medication was taken.1

MHD=migraine headache day; MSQ v2.1=Migraine-Specific Quality of Life Questionnaire version 2.1.

Reference: 1. Emgality [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2018. 2. Data on file. Lilly USA, LLC. BSD-GZ-US-0007. 3. Data on file. Lilly USA, LLC. BSD-GZ-US-0008. 4. Data on file. Lilly USA, LLC. BSD-GZ-US-0006.