Emgality® Versus Nurtec® ODT Head-to-Head Migraine Preventive Treatment Study Now Enrolling Patients
While Nurtec ODT and Emgality are both medications that target CGRP, because Emgality is a monoclonal antibody (mAb) that binds to CGRP (a protein found in the brain thought to play a key role in migraine), it works differently than gepants like Nurtec ODT, that bind to and block the CGRP receptor.2-4 Emgality is the only CGRP medication with ≥50%, ≥75% and 100% reductions of monthly migraine headache days in its label for people with episodic migraine experiencing 4 to 14 migraine headache days per month.
"Migraine can greatly impact day-to-day activities, robbing people of their routines and their everyday and special occasions in life. Reducing the frequency of migraine attacks can help people achieve more migraine-free days and enjoy an improved quality of life; both of which are essential treatment goals," said
The CHALLENGE-MIG clinical trial is expected to enroll approximately 700 adults across the
About the CHALLENGE-MIG Study
In the first head-to-head clinical trial comparing two medications targeting calcitonin gene-related peptide (CGRP), the CHALLENGE-MIG is a randomized, double-blind, placebo-controlled Phase 4 study in adult patients who meet the International Classification of Headache Disorders-3 (ICHD-3) criteria for a diagnosis of migraine with or without aura and experiencing 4-14 migraine headache days per month. The study aims to evaluate the efficacy and safety of once-monthly injectable Emgality® (galcanezumab-gnlm) compared to every-other-day Nurtec® ODT (rimegepant) taken orally. The primary endpoint is ≥50% reduction from baseline in monthly migraine headache days across the 3-month double-blind treatment period. Secondary endpoints include ≥75% and 100% reduction from baseline in monthly migraine headache days and improvements in the Migraine-Specific Quality of Life (MSQ), a 14-item questionnaire designed to measure migraine-specific health-related quality of life by assessing the limitation of daily performance, and the Migraine Disability Assessment (MIDAS), a five-item questionnaire used to assess headache-related disability in the past three months.
Emgality is a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP) and was approved by the FDA in September 2018 for the preventive treatment of migraine in adults. Emgality is the only CGRP monoclonal antibody with response rates in the episodic migraine headache population on ≥50%, ≥75% and 100% reduction from baseline in monthly migraine headache days over Months 1 to 6 included in its Full Prescribing Information. In June 2019, Emgality was approved by the FDA for the treatment of episodic cluster headache in adults.
Indications and Usage for Emgality (galcanezumab-gnlm) 120 mg Injection
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 for Emgality
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Warnings and Precautions
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.
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.
GZ HCP ISI 10DEC2019
Migraine is a severely disabling neurologic disease characterized by recurrent episodes of moderate to severe headache accompanied by other symptoms including nausea, sensitivity to light, and sensitivity to sound.5,6 More than 30 million American adults have migraine, with three times more women than men affected by migraine.7 Migraine is often incapacitating, leading to high personal, societal and economic burden. According to the
For more than 25 years,
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Emgality (galcanezumab-gnlm) as a preventive treatment for patients with migraine and as a treatment for patients with episodic cluster headache, and reflects
All product/company names shown herein are the trademarks of their respective owners.
- A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Galcanezumab Versus Rimegepant in Adult Participants with Episodic Migraine.
- Emgality [Prescribing Information].
Indianapolis, IN: Lilly USA, LLC.
- Russo AF. Calcitonin gene-related peptide (CGRP): a new target for migraine. Annu Rev Pharmacol Toxicol. 2015;55:533-552.
- Garza I, Swanson JW. Prophylaxis of migraine. Neuropsychiatr Dis Treat. 2006;2(3):281-291.
- Katsarava Z, Buse D, Manack A, et al. Defining the differences between episodic migraine and chronic migraine. Current Pain Headache Reports. 2012;16:86.
- Blumenfeld AM, Payne KA, Varon SF, et al. Disability, HRQOL, and resource use amongst chronic and episodic migraineurs. Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301.
- Lipton RB, Bigal ME, Diamond M, et al., Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343-349.
- Raval AD,
Shah A. Nationaltrends in direct health care expenditures among U.S.adults with migraine: 2004 to 2013. Journal of Pain. 2017;57:60.
Kevin Hern; firstname.lastname@example.org; 317-277-1838 (Investor Relations)
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