Migraine Headache Day (MHD) Reduction Data

For your patients with ≥15 headache days per month,

Emgality delivered significantly more migraine-free days vs placebo1

Emgality demonstrated an average reduction of 4.8 mean MHDs per month vs 2.7 mean MHDs per month with placebo (baseline mean: 19.4 vs 19.6) (p<0.001)1

For your patients with ≥15 headache days per month,

Emgality reduced mean monthly MHDs in the first month and every following month1

Emgality demonstrated reductions in MHDs in every month of the 3-month treatment period, on average1

Change From Baseline in Monthly MHDs (REGAIN) chart

aLeast-square (LS) means and 95% confidence intervals are presented.
bEarliest post-baseline, prespecified assessment.

REGAIN: -4.1 mean MHDs with Emgality in the first month vs -1.8 mean MHDs with placebo4

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.

For your patients with ≥15 headache days per month,

Assessment of change in the number of monthly MHDs acute medication was used in REGAIN1

Emgality 120 mg was not statistically different from placebo for reduction in mean MHDs with acute medication use, 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.

For your patients with ≥15 headache days per month,

Change in monthly MHDs in patients with or without baseline acute medication overuse1,5a

Mean Change From Baseline in the Number of Monthly MHDs in Patients With or Without Baseline Acute Medication Overuse<sup>5a</sup>

aMedication overuse was defined as exceeding the following thresholds for total days of use of any of the following drug classes (or medications containing drugs from these classes) per 30-day period of the prospective baseline period as reported in an electronic diary6:

  • Any triptan for ≥10 days
  • Any NSAID or aspirin for ≥15 days
  • Any acetaminophen/paracetamol for ≥15 days
  • Any ergot or ergotamine derivative for ≥10 days
  • Any combination drugs containing 2 or more of the above medication classes for ≥10 days
  • Total days with drug use from at least 2 of the above categories ≥10 days

Post-hoc repeated measures subgroup analysis of REGAIN data. As this analysis was post hoc, treatment differences observed in this subgroup cannot be regarded as statistically significant. Patients were excluded from the study if they used opioids or barbiturate-containing analgesics >3 times per month for the treatment of pain in more than 2 of the 6 months prior to the study.

See Study Design for REGAIN

See Data for Episodic Migraine

SELECT IMPORTANT SAFETY INFORMATION
Adverse Reactions

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

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