Response rates

For your patients with 4-14 MHDs per month,

Emgality makes it possible for some patients to be totally migraine headache-free for a month1

Emgality demonstrated ≥50%, ≥75%, and 100% reductions in monthly MHDs from baseline for a significantly greater mean percentage of patients vs placebo (p<0.001)1

Mean Percentage of Patients Meeting Defined Levels of Reduction in Monthly MHDs EVOLVE-1 EVOLVE-2 chart

ap<0.001 vs placebo.

>=50% reduction in monthly MHDs from baseline
>=75% reduction in monthly MHDs from baseline
100% reduction in monthly MHDs from baseline

See Study Design for EVOLVE-1 and EVOLVE-2

See Data for Chronic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Contraindications

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

For your patients with 4-14 MHDs per month,

100% reduction of monthly MHDs in at least 1, 2, or 3 months1,10

Percentage of Patients Experiencing 100% Reduction in Monthly MHDs in at Least 1, 2, or 3 Months in the 6-Month Treatment Period Pooled EVOLVE-1 EVOLVE-2 chart

Post-hoc analyses of EVOLVE-1 and EVOLVE-2 pooled data. Results reported are simple calculations of percentages. As these analyses are post hoc, no conclusions of statistical or clinical significance can be drawn.

See Study Design for EVOLVE-1 and EVOLVE-2

For your patients with 4-14 MHDs per month,

≥50% reduction of mean monthly MHDs for Months 1 to 3 and Months 4 to 61,11

≥50% Reduction in Monthly MHDs in Months 1-3 and Months 4-6 chart

Post-hoc analysis of EVOLVE-1 and EVOLVE-2. No conclusions of statistical or clinical significance can be drawn. The mean monthly percentage of patients meeting response criteria during Months 1 to 3 and Months 4 to 6 of the double-blind treatment phase was estimated using generalized linear repeated measures models.

See Study Design for EVOLVE-1 and EVOLVE-2

For your patients with 4-14 MHDs per month,

≥50% reduction of monthly MHDs in preventive-naïve patients and patients who failed ≥1 or ≥2 preventives1,12-14

Subgroup Analysis of >=50% Responders in Reduction of Monthly MHDs in Preventive Naïve and Prior Preventive Treatment Exposed<sup>12-14</sup>

Post-hoc analysis of EVOLVE-1 and EVOLVE-2 pooled data. The studies were not adequately powered nor error-controlled for subgroup analyses. Treatment differences observed in these subgroups 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 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 were naïve, failed ≥1, and 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.15

See Study Design for EVOLVE-1 and EVOLVE-2

See Data for Chronic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, angioedema, dyspnea, urticaria, and rash, have been reported with Emgality. Hypersensitivity reactions can occur days after administration and may be prolonged.

Emgality
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