Response Rates

For your patients with ≥15 headache days per month,

Emgality reduced monthly MHDs from baseline by at least half in a significantly greater mean percentage of patients: 28% of patients (p<0.001)1

Chronic ≥50% Reduction Months 1 to 3 (REGAIN) chart

ap<0.001 vs placebo.

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 Data for Episodic Migraine

For your patients with ≥15 headache days per month,

≥50% reduction of mean monthly MHDs from baseline in patients who failed ≥2 preventive treatments1,7

Subgroup Analysis of >=50% Responders in Reduction of Monthly MHDs in Patients Who Failed >=2 Preventive Treatments<sup>7</sup>

Post-hoc analysis of REGAIN. The REGAIN study was not adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in this subgroup cannot be regarded as statistically significant. Patients were excluded from the study if they had failed to respond to 3 or more adequately dosed migraine preventive treatments from different classes (that is, maximum tolerated dose for at least 2 months). Failure to respond due to tolerability issues was not considered an exclusion criterion. Migraine preventive treatments are defined as Level A and Level B of the American Academy of Neurology’s Evidence-based Guideline Update: Pharmacologic Treatment for Episodic Migraine Prevention in Adults as well as botulinum toxin A or B. Assignment to the subgroup of patients who failed <2 or failed >2 individual preventive medications was based on patient report of previous discontinuation of a migraine preventive due to lack of efficacy, suboptimal efficacy, or intolerability.8

See Study Design for REGAIN

See Data for Episodic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Contraindications

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

Emgality

Impact of Migraine

For your patients with ≥15 headache days per month,

Assessment of MSQ v2.1 RF-R domain in REGAIN1

Emgality 120 mg was not statistically different from placebo for mean change in MSQ v2.1 RF-R over the 3-month treatment period, after controlling for multiple comparisons.1

See Study Design for REGAIN

See Data for Episodic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, urticaria, and rash, have been reported with Emgality. 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.

Get eligible patients started today with the Emgality savings card


References: 1. Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Data on File. Lilly USA, LLC. DOF-GZ-US-0019. 3. Bagley CL, Rendas-Baum R, Maglinte GA, et al. Validating Migraine-Specific Quality of Life Questionnaire v2.1 in episodic and chronic migraine. Headache. 2012;52:409-421. 4. Data on File. Lilly USA, LLC. DOF-GZ-US-0002. 5. Data on File. Lilly USA, LLC. DOF-GZ-US-0057. 6. Data on File. Lilly USA, LLC. DOF-GZ-US-0024. 7. Data on File. Lilly USA, LLC. DOF-GZ-US-0056. 8. Silberstein SD, Holland S, Freitag F, et al. Evidence-based guideline update: Pharmacologic treatment for episodic migraine prevention in adults. Neurology. 2012;78:1337-1345.

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 anaphylaxis, angioedema, dyspnea, urticaria, and rash, have been reported with Emgality. 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 04JUN2019