Our Website Uses Cookies. We and third parties we work with use cookies to collect information about your internet browsing activities to provide you relevant content and advertising on this and other websites, media and devices you use, and to understand your interests to improve the site. For more information on our use of cookies, please view our full Privacy Statement. Click "OK" to continue.

EMGALITY HOME

FOR CONSUMERS

EPISODIC CLUSTER HEADACHE HOME
HEALTHCARE PROVIDERS HOME

FOR HEALTHCARE PROVIDERS

Efficacy - Chronic Migraine

Study Design

The efficacy and safety of Emgality were evaluated in chronic migraine in a Phase 3 trial1,2

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the US and 11 other countries1,2

REGAIN: A 3-month, double-blind, placebo-controlled study that enrolled 1113 adult patients with chronic migraine (defined as ≥15 headache days per month with ≥8 migraine days per month). Participants were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. 240 mg is an unapproved dose. Patients were allowed to use acute headache treatments including migraine-specific medications (ie, triptans, ergotamine derivatives), nonsteroidal anti-inflammatory drugs (NSAIDs), and acetaminophen during the study. A subset of patients (15%) continued 1 concomitant migraine preventive medication. Patients with medication overuse headache were allowed to enroll. Patients were excluded if they had electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event and patients with a history of stroke myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, deep vein thrombosis, or pulmonary embolism within 6 months of screening. The primary endpoint was the mean change from baseline in the number of monthly migraine headache days (MHDs) over the 3-month treatment period.<sup>1</sup>

aMSQ v2.1 is a self-administered tool developed to assess the impact of migraine on patients’ health-related quality of life. Areas measured included: relationships with family and friends, leisure time, productivity, concentration, energy, and tiredness. Scores are scaled from 0 to 100, with higher scores indicating less impact of migraine on daily activities.1,3

See Study Design for EVOLVE-1 and EVOLVE-2

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

Are you a US healthcare provider?

The information contained in this section of Emgality.com is intended for US healthcare providers. Please confirm below.

No

You are now leaving Emgality.com.

The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

Click “Continue” to leave site or “Return to Emgality.com” to close this window and return to Emgality.com.

Are you a US healthcare provider?

The information contained in this section of Emgality.com is intended for US healthcare providers. Please confirm below.