Results from a 12-month, open-label safety study in patients with 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

No new safety findings were identified for Emgality over a 12-month treatment period¹

Treatment-emergent adverse events (TEAEs) were predominantly rated as mild or moderate in severity.²

• 54 patients on Emgality 120 mg experienced a TEAE possibly related to study treatment during the 12-month treatment period. The most prevalent TEAEs were injection site pain, injection site reaction, and injection site erythema.^1,2
• 6 patients discontinued Emgality 120 mg due to adverse events. 2 patients discontinued due to injection site reaction, 1 patient discontinued due to injection site erythema, and 1 patient discontinued due to lethargy. Other discontinuations due to adverse events were not determined to be related to study treatment.^1-3
• Of the 54 TEAEs possibly related to study treatment, 27 were deemed mild, 21 were deemed moderate, and 6 were deemed severe.⁴

Review study design for the 12-month, open-label safety study

Secondary Endpoint Result

Overall mean change from baseline in the number of monthly MHDs over Months 1 to 12¹

These are observations from the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled. Results should be interpreted with these factors in mind.¹

Review study design for the 12-month, open-label safety study
Review data for episodic migraine
Review data for chronic migraine

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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.

Reductions in mean monthly MHDs observed during the 12-month treatment period with Emgality^1,5

^aLeast-square (LS) means and 95% confidence intervals are presented.

These are observations from the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled. These findings cannot be considered statistically significant.¹

Patient N is based on the number of patients who reported MHD data each month.^1,5

Review study design for the 12-month, open-label safety study
Review data for episodic migraine
Review data for chronic migraine

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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.

Secondary Endpoint Result

Reductions in mean monthly MHDs observed in patients with episodic migraine taking Emgality 120 mg^1,6,7

^aLeast-square (LS) means are presented.

These are observations from a post hoc analysis of the episodic migraine subpopulation in the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled.^6,7

Patient N is based on the number of patients who reported MHD data each month.^1,6

Review study design for the 12-month, open-label safety study
Review 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.

Secondary Endpoint Result

Reductions in mean monthly MHDs observed in patients with chronic migraine taking Emgality 120 mg^1,6,7

^aLeast-square (LS) means are presented.

These are observations from a post hoc analysis of the chronic migraine subpopulation in the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled.^6,7

Patient N is based on the number of patients who reported MHD data each month.^1,6

Review study design for the 12-month, open-label safety study
Review data for chronic 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.

Secondary Endpoint Result

Percentage of patients with ≥50%, ≥75%, and 100% reductions in monthly MHDs from baseline over Months 1 to 12¹

These are observations from the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled. Results should be interpreted with these factors in mind.¹

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.⁸

Review study design for the 12-month, open-label safety study
Review data for episodic migraine
Review data for chronic 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.

The percentage of patients with ≥50% reduction in mean monthly MHDs observed during the 12-month treatment period with Emgality^1,9

These are observations from the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled. These findings cannot be considered statistically significant.¹

Patient N is based on the number of patients who reported MHD data each month.^1,9

Review study design for the 12-month, open-label safety study
Review data for episodic migraine
Review 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.

Emgality was studied in patients with episodic or chronic migraine in a 12-month, Phase 3 trial¹

The trial was a 12-month, open-label, multicenter study assessed primarily for safety and tolerability and, secondarily, for effectiveness in patients with episodic or chronic migraine¹

Patient population (N=270)¹

• 79% of patients enrolled were diagnosed with episodic migraine
• 21% of patients enrolled were diagnosed with chronic migraine
• Patients 18 to 65 years of age
• Migraine was defined as:
  
  • Meeting International Classification of Headache Disorders-3 beta (ICHD-3 beta) criteria for diagnosis
• A history of at least 1 year of migraine headaches
• Migraine onset prior to 50 years of age
• A history of ≥4 MHDs per month, on average, for 3 months prior to study entry
• A history of at least 1 headache-free day per month for 3 months prior to study entry

Exclusion criteria¹

• Patients with prior exposure to Emgality or any other calcitonin gene-related peptide (CGRP) antibody treatment
• Patients on any antibody therapy 12 months prior to study entry
• Patients on a migraine preventive treatment
• Patients who failed on ≥3 classes of migraine preventive treatments (as defined by the American Academy of Neurology treatment guidelines Level A or Level B evidence)
• Patients with certain medical conditions, including pregnancy, suicidal ideation within 1 month prior to study entry, and substance abuse or dependence within 1 year of study entry
• Patients with acute cardiovascular events and/or serious cardiovascular events based on history or electrocardiogram (ECG) findings

Study Period 1 (3-45 days)¹

• Initial screening procedures
• Washout of all migraine preventive treatments

Study Period 2 (open-label treatment period)^1,8

• Patients were randomized to once-monthly Emgality 120 mg (N=135) or Emgality 240 mg (N=135) for 12 doses total
  
  • Patients on Emgality 120 mg received an initial loading dose of 240 mg and all subsequent doses were 120 mg
  • Patients on Emgality 240 mg received 240 mg each month. 240 mg is not an approved dose
• Acute medications^a (ie, triptans, ergots, nonsteroidal anti-inflammatory drugs [NSAIDs], and acetaminophen) for the treatment of migraine were allowed
• Treatment was delivered by prefilled syringe or autoinjector by patients or caregivers (after appropriate training)
• Patients kept track of their headaches (migraine and non-migraine) and use of medication taken for acute treatment of migraine and non-migraine headache for the last 30 days, every month of the 12-month study
• Patients were required to report a migraine headache, headache, or the use of acute medication on a daily basis with a diary or log for monthly review

Study Period 3 (washout phase)¹

• Patients no longer received treatment, but continued to track headache information and received safety assessments for 4 months in the post-treatment period

Prespecified key endpoints¹

• Primary endpoint: Safety and tolerability of Emgality for up to 1 year of treatment
• Secondary endpoint: Effectiveness of Emgality as assessed by the overall mean change from baseline and mean percentage of patients with ≥50%, ≥75%, and 100% reduction from baseline in the number of monthly MHDs over 12 months of treatment¹

These are observations from the 12-month, open-label safety study of which efficacy measures were a secondary endpoint. Data from the open-label safety study have limitations, as the study was not blinded or placebo-controlled. Results should be viewed with these factors in mind.¹

^aExcept opiods and barbiturates taken more than 3 times per month.

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.