Discover what Emgality can do for patients with chronic migraine¹

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

Primary Endpoint Result

Emgality made it possible to have nearly 5 fewer migraine headache days (MHDs) per month on average¹

Review study design for REGAIN
See data for episodic migraine or the 12-month, open-label safety study

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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.

Emgality makes a difference after the first dose^1,3

Difference from placebo observed at Month 1^1,3

No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month. However, patients treated with Emgality 120mg showed a nominally greater reduction in number of monthly MHDs at each month compared to placebo.^1,3

Review study design for REGAIN
See data for episodic migraine or the 12-month, open-label safety study

Secondary Endpoint Result

With Emgality, a significantly greater mean percentage of patients achieved a ≥50% reduction in monthly migraine headache days (MHDs) from baseline vs placebo¹

^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. Statistical significance vs placebo was not observed after controlling for multiple comparisons for mean change in Migraine-Specific Quality of Life version 2.1 (MSQ v2.1) Role-Function Restrictive (RF-R) or for reduction in mean MHDs with acute medication use.¹

Review study design for REGAIN
See data for episodic migraine or the 12-month, open-label safety study

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 demonstrated a ≥50% reduction in monthly MHDs from baseline for a greater mean percentage of patients¹

No formal hypothesis testing was conducted to evaluate treatment differences observed at each month of the treatment period. Values should not be considered statistically significant.

Review study design for REGAIN
See data for episodic migraine or the 12-month, open-label safety study

Secondary Endpoint Result

Mean change in monthly migraine headache days (MHDs) in patients with ≥2 prior preventive failures⁵

Post hoc analysis of REGAIN. The REGAIN study was neither 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 (that is, maximum tolerated dose for at least 2 months) migraine preventive treatments from different classes. 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.⁶

Review 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.

Change in mean monthly MHDs in patients with or without baseline acute medication overuse^7a

^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 diary⁸:

• Any triptan for ≥10 days
• Any nonsteroidal anti-inflammatory drug (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 for ≥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.

Review study design for REGAIN
See data for episodic migraine

SELECT IMPORTANT SAFETY INFORMATION
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.

Emgality was studied as a preventive treatment for chronic migraine in a Phase 3 trial^1,9

REGAIN was a 3-month, randomized, multicenter, double-blind, placebo-controlled study conducted in the United States and 11 other countries^1,9

Adult patient population (N=1113)^1,9

• Patients with ≥15 headache days per month, at least 8 of which had the feature of migraine
• Migraine was defined as:
  
  • Lasting 30 minutes or more
  • Meeting International Classification of Headache Disorders-3 beta (ICHD-3 beta) criteria for diagnosis
• Patients with medication overuse headache were allowed to enroll

Exclusion criteria¹

• Patients with electrocardiogram (ECG) abnormalities compatible with an acute cardiovascular event
• 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

3-month treatment period¹

• Participants were randomized to once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. 240 mg is an unapproved dose
• Acute treatments for headache, including migraine-specific medications (ie, triptans, ergotamine derivatives), nonsteroidal anti-inflammatory drug (NSAIDs), and acetaminophen were allowed
  
  • 15% of patients continued 1 concomitant preventive treatment

Prespecified key endpoints^1,2

• Primary endpoint: Least-square (LS) mean change from baseline in the number of monthly MHDs over Months 1 to 3
• Secondary endpoint: Mean percentage of patients with ≥50%, ≥75%, and 100% reduction from baseline in the number of monthly MHDs over Months 1 to 3

Additional key secondary endpoints¹

• Impact of migraine on daily activities, as assessed by the mean change from baseline in the average Migraine-Specific Quality of Life version 2.1 (MSQ v2.1) Role Function-Restrictive (RF-R) domain score at Month 3^a
• Mean change from baseline in the number of monthly MHDs with use of any acute medication for headache during the 3-month treatment period

^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.^1,10

Review study design for EVOLVE-1 and EVOLVE-2

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