Emgality®: a once-monthly preventive treatment for patients with episodic or chronic migraine1
Emgality can reduce the impact of migraine during and between attacks
- Decreases the number of monthly migraine headache days
See data on MHD reduction - Improves patient functioning
See data on impact on daily activities - See data on decreasing burden related to migraine between attacks2
INDICATIONS
Emgality is a calcitonin gene-related peptide (CGRP) antagonist indicated in adults for the preventive treatment of migraine and the treatment of episodic cluster headache.
SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Meet Jessicaa
Migraine continues to impact her work and personal life during and between attacks
- 4-14 unpredictable migraine headache days (MHDs) per month
- Has tried therapeutic doses of 2 standard-of-care generic preventives
- May now be only relying on her acute treatments
She isn't sure another preventive will give her the results she is looking for.
aHypothetical patient profile with episodic migraine.
SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
The impact of migraine can go beyond frequency of attacks3
BURDEN OF MIGRAINE DURING ATTACKS
91% of patients with migraine cannot function normally during migraine headache attacks4
BURDEN OF MIGRAINE BETWEEN ATTACKS
68% of patients had moderate to severe burden of migraine as reported in OVERCOME5a
OVERCOME STUDY DESIGN5: Adults from the United States, Spain, Germany, and Japan who reported ≥1 headache or migraine in the past 12 months that were not all due to illness or hangover and met modified ICHD-3 criteria for migraine using the validated American Migraine Study/AMPP Study migraine diagnostic questionnaire completed a web-based, population-based survey to quantify overall and country-specific rates of self-reported medical diagnosis of migraine and disease burden among respondents.
aAmong respondents from the United States who met ICHD-3 criteria for migraine and self-reported a medical diagnosis of migraine.5
AMPP=American Migraine Prevalence and Prevention; ICHD-3=International Classification of Headache Disorders version 3; MIBS-4=Migraine Interictal Burden Scale-4.
Emgality can reduce the impact of migraine during and between attacks
- Decreases the number of monthly migraine headache days
See data on MHD reduction - Improves patient functioning
See data on impact on daily activities - See data on decreasing burden related to migraine between attacks2
Emgality is the first and only calcitonin gene-related peptide (CGRP) antibody approved for both migraine and episodic cluster headache in adults1,5
Primary Endpoint Data
For your patients with 4-14 MHDs per month,
Emgality can provide the power of MHD reduction1
Emgality prevented significantly more mean monthly MHDs vs placebo1a:
- EVOLVE-1: 4.7 with Emgality vs 2.8 with placebo (baseline mean: 9.2 vs 9.1) over Months 1 to 6 (p<0.001)
- EVOLVE-2: 4.3 with Emgality vs 2.3 with placebo (baseline mean: 9.1 vs 9.2) over Months 1 to 6 (p<0.001)
aLS means and 95% confidence intervals are presented.1,7,19
bEarliest post-baseline, prespecified assessment.
EVOLVE-1
Mean change from baseline in monthly MHDs at each month over Months 1 to 6 in EVOLVE-11,7a:
- Month 1: Emgality following the loading dose of 240 mg was -3.7b vs - 1.7b for placebo
- Month 2: Emgality 120 mg was -4.4 vs -2.5 for placebo
- Month 3: Emgality 120 mg was -4.7 vs -3.0 for placebo
- Month 4: Emgality 120 mg was -5.1 vs -3.2 for placebo
- Month 5: Emgality 120 mg was -5.4 vs -3.1 for placebo
- Month 6: Emgality 120 mg was -5.2 vs -3.4 for placebo
210 patients were treated with Emgality 120 mg vs 425 patients treated with placebo.
EVOLVE-2
Mean change from baseline in monthly MHDs at each month over Months 1 to 6 in EVOLVE-21,7a:
- Month 1: Emgality following the loading dose of 240 mg was -3.9b vs - 1.2b for placebo
- Month 2: Emgality 120 mg was -4.0 vs -2.2 for placebo
- Month 3: Emgality 120 mg was -3.8 vs -2.2 for placebo
- Month 4: Emgality 120 mg was -4.5 vs -2.4 for placebo
- Month 5: Emgality 120 mg was -4.9 vs -2.9 for placebo
- Month 6: Emgality 120 mg was -4.6 vs -2.9 for placebo
226 patients were treated with Emgality 120 mg vs 450 patients treated with placebo.
No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month.7,19
See study design for EVOLVE-1 and EVOLVE-2For your patients with ≥15 headache days per month,
Emgality demonstrated a reduction in MHDs in the first month and every following month1
Emgality prevented significantly more mean monthly MHDs vs placebo1a:
- REGAIN: 4.8 with Emgality vs 2.7 with placebo (baseline mean: 19.4 vs 19.6) over Months 1 to 3 (p<0.001)
aLS means and 95% confidence intervals are presented.1,7,19
bEarliest post-baseline, prespecified assessment.
Mean change from baseline in monthly MHDs at each month over Months 1 to 3 in REGAIN1,7a:
- Month 1: Emgality following the loading dose of 240 mg was -4.1b vs - 1.8b for placebo
- Month 2: Emgality 120 mg was -5.0 vs -3.0 for placebo
- Month 3: Emgality 120 mg was -5.4 vs -3.4 for placebo
273 patients were treated with Emgality 120 mg vs 538 patients treated with placebo.
No formal hypothesis testing was conducted to evaluate treatment difference in mean monthly MHD reduction at each month.1,7
Review study design for EVOLVE-1 and EVOLVE-2
Review study design for REGAIN
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 Results
For your patients with 4-14 migraine headache days (MHDs) per month,
Emgality makes it possible for some patients to be totally migraine-free for a month1
In two clinical studies, 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
bp<0.001 vs placebo.
EVOLVE-1
Response rates defined levels of reduction in monthly MHDs over Months 1 to 6 in EVOLVE-11:
- Mean percentage of patients who experienced a ≥50% reduction in MHDs with Emgality 120 mg was 62% vs 39% with placebo
- Mean percentage of patients who experienced a ≥75% reduction in MHDs with Emgality 120 mg was 39% vs 19% with placebo
- Mean percentage of patients who experienced a 100% reduction in any month of the 6-month study was 16% with Emgality vs 6% with placebo
210 patients were treated with Emgality and 425 patients were treated with placebo.
EVOLVE-2
Response rates defined levels of reduction in monthly MHDs over Months 1 to 6 in EVOLVE-21:
- Mean percentage of patients who experienced a ≥50% reduction in MHDs with Emgality 120 mg was 59% vs 36% with placebo
- Mean percentage of patients who experienced a ≥75% reduction in MHDs with Emgality 120 mg was 34% vs 18% with placebo
- Mean percentage of patients who experienced a 100% reduction in any month of the 6-month study was 12% with Emgality vs 6% with placebo
226 patients were treated with Emgality and 450 patients were treated with placebo.
For your patients with ≥15 headache days per month,
In REGAIN, Emgality 120 mg (N=273) reduced monthly MHDs from baseline by ≥50% in a significantly greater mean percentage of patients: 28% of patients vs 15% of patients with placebo (N=538) over Months 1 to 3 (p<0.001).1
Emgality 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.1
Review study design for EVOLVE-1 and EVOLVE-2
Review study design for REGAIN
Review response rates from the 12-month, open-label safety study
Emgality has demonstrated a consistent safety profile in migraine and episodic cluster headache1,6,8,9
The most frequent adverse reactions with Emgality in the EVOLVE-1, EVOLVE-2, and REGAIN clinical trials were injection site reactions1
Adverse reactions occurring in adults with migraine with an incidence of at least 2% for Emgality and at least 2% greater than placebo1
EVOLVE-1, EVOLVE-2 and REGAIN (up to 6 months of treatment)
Adverse Reaction
|
Emgality 120 mg Monthly (N=705)
|
Placebo Monthly (N=1451)
|
|---|---|---|
| Adverse Reaction: Injection site reactionsa | Emgality 120 mg Monthly (N=705): 18% | Placebo Monthly (N=1451): 13% |
aInjection site reactions include multiple-related adverse event terms, such as injection site pain, injection site reaction, injection site erythema, and injection site pruritus.
Review study design for EVOLVE-1 and EVOLVE-2
Review study design for REGAIN
In a 12-month, open-label safety study of patients with episodic or chronic migraine with 4 or more migraine headache days (MHDs) per month,
No new safety findings were identified for Emgality over a 12-month treatment period10
- 54 patients on Emgality 120 mg experienced a treatment-emergent adverse event (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 erythema10,11
- 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 treatment10-12
Review study design from a 12-month, open-label safety study
The safety of Emgality 300 mg was also evaluated for up to 2 months in a placebo-controlled study in patients with episodic cluster headache.4b
Overall, the safety profile observed in patients with episodic cluster headache treated with Emgality 300 mg monthly was consistent with the safety profile in migraine patients.
- 2 patients treated with Emgality discontinued double-blind treatment because of adverse events
bEmgality Episodic Cluster Headache Study: Emgality 300 mg (N=49), placebo (N=57).
According to the American Headache Society,
Adherence can be affected by dosing frequency13
Patients who are poorly adherent to a daily orally-administered drug may be more likely to adhere to a once-monthly injectable CGRP antagonist like Emgality.13,14a
aAt the time the American Headache Society statement was published, no oral gepant had been FDA-approved for migraine prevention.13
For your patients with migraine,
Recommended dosing with no titration required1b:
- Month 1: Initial loading dose of 240 mg (two 120-mg injections)
- Subsequent months: One 120-mg injection per month
bThe Emgality Pen and prefilled syringe needles are 27 gauge x 1/2 inch.15
See dosing for episodic cluster headache
Please review the full Instructions for Use with your patients to ensure they understand how to properly administer Emgality.
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.
*Based on total prescriptions of subcutaneous calcitonin gene-related peptide (CGRP) antibody injections written after 12/31/2021. Data as of 1/27/2023.
Source: IQVIA database as of 1/27/2023 and is subject to change without notice.
†Best-in-class commercial access indicates the subcutaneous CGRP antibody injection on prescription drug plans with pharmacy benefit coverage for the most lives at or equivalent to Preferred, Covered, Specialty, or Generic on all commercial plans for the preventive treatment of migraine.1 Does not take into consideration any restrictions set forth by individual plans. Data as of 2/8/2023.
Source: Managed Markets Insight & Technology (MMIT), LLC as of 2/8/2023 and is subject to change without notice. Please contact the plan or state for the most current information. “Coverage” includes all statuses at or equivalent to Preferred, Covered, or Specialty for the preventive treatment of migraine. This information is not a guarantee of coverage or payment (partial or full). Actual benefits are determined by each plan administrator in accordance with its respective policy and procedures. Employers and employer groups may also offer additional benefit designs, which may be different than described.
Have questions about Emgality?
Call us at 1-833-EMGALITY (1-833-364-2548).
SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
For your eligible, commercially insured patients with migraine or episodic cluster headache,
Get your patients started on Emgality: 1 savings card* for 2 headache conditions1
Patients can get Emgality for as little as $0 for up to 12 months
The Emgality Savings Card:
Start treatment Today. Save for up to 12 months.
- HCP Prescribes Emgality and pursues PA approval
- Patient activates savings card and picks up first fill
- Pay as little as $0 for Emgality for up to 12 months once PA is approvedb
bPatients need PA approval by second fill and insurance must continue to cover the claim for patients to pay as little as $0 for up to 12 months.
Help patients save with the Emgality Savings Card*
*Terms and Conditions:
Offer good for up to 12 months of Emgality from Patient qualification into the program. Patients that have commercial drug insurance coverage for Emgality may be able to pay as little as $0 for a 30-day supply of Emgality. Offer subject to a monthly cap of wholesale acquisition cost plus usual and customary pharmacy charges and a separate annual cap of $4,900. Patients that have commercial drug insurance but do not have coverage for Emgality may be able to pay as little as $0 for their first fill of a 30-day supply of Emgality. Patient is responsible for any applicable taxes, fees, or amounts exceeding monthly or annual caps. This offer is invalid for Patients without commercial drug insurance or whose prescription claims for Emgality are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DoD, VA, TRICARE®/CHAMPUS, or any State Patient or Pharmaceutical Assistance Program. Offer void where prohibited by law and subject to change or discontinue without notice. Card activation is required. Subject to additional terms and conditions, which can be found
here.
PA=prior authorization.
TRICARE® is a registered trademark of the Department of Defense (DoD), DHA. All rights reserved.
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.
MHD=migraine headache day.
View additional data for patients with migraine, including results from a 12-month, open-label safety study, and the CONQUER study
References:
- Emgality [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
- García-Azorín D, Ford J, Buse DC, et al. Changes in work productivity and interictal burden: results from randomized, double-blind study evaluating galcanezumab in adults with treatment resistant migraine (CONQUER). Presented at: 17th Asian Oceanian Congress of Neurology (AOCN 2021); Taipei, Taiwan; April 1-4, 2021.
- Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84:422-435.
- Lipton R, Stewart W, Diamond S, et al. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001;41(7):646-657.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0179.
- Mulleners WM, Kim BK, Láinez MJA, et al. Safety and efficacy of galcanezumab in patients for whom previous migraine preventive medication from two to four categories had failed (CONQUER): a multicentre, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2020;19:814-825.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0002.
- Bangs ME, Kudrow D, Wang S, et al. Safety and tolerability of monthly galcanezumab injections in patients with migraine: integrated results from migraine clinical studies. BMC Neurol. 2020;20:90. doi:10.1186/s12883-020-1609-7.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0107.
- Camporeale A, Kudrow D, Sides R, et al. A phase 3, long-term, open-label safety study of galcanezumab in patients with migraine. BMC Neurol. 2018;18(1):188. doi:10.1186/s12883-018-1193-2.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0137.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0139.
- Ailani J, Burch RC, Robbins MS; the Board of Directors of the American Headache Society. The American Headache Society consensus statement: update on integrating new migraine treatments into clinical practice. Headache. 2021;00:1-19.
- Loder E, Burch R, Rizzoli P. The 2012 AHS/AAN guidelines for prevention of episodic migraine: a summary and comparison with other recent clinical practice guidelines. Headache. 2012;52:930-945.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0060.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0190.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0181.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0189.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0120.