Lilly Announces Head-to-Head Study Comparing Once-Monthly Emgality® with Every-Other-Day Nurtec® ODT for the Preventive Treatment of Migraine
The study, which is the first head-to-head clinical trial comparing two medications targeting CGRP, is a multi-site, randomized, double-blind, double-dummy, parallel-group Phase 4 study in patients who meet the International Classification of Headache Disorders (ICHD) criteria for a diagnosis of episodic migraine with or without aura. There will be two treatment arms: Emgality 120 mg once-monthly injection, with an initial 240 mg loading dose, and Nurtec ODT 75 mg, taken every other day. The study's primary endpoint is 50% reduction in monthly migraine headache days. Enrollment is expected to begin later this year.
"Migraine is a painful, burdensome and complex neurologic disease. Every person's experience is different. Providing patients with options and individualized treatment plans is vitally important," said
Emgality is the only CGRP therapy that includes ≥50%, ≥75% and 100% reduction in monthly migraine headache days for the duration of the treatment period for episodic migraine patients, in its FDA-approved labeling. Emgality's adherence and persistence findings were recently presented at AHS, and insights about interictal burden (impact of migraine between migraine attacks) were shared previously.
"This year, we are proud to help more than 700,000 Emgality patients. We encourage HCPs and patients to talk about the preventive treatment goal of freedom from migraine through reduced frequency of attacks, which can also result in greater quality of life and functional improvements. We believe people should expect more and get more from their migraine medications," said Yuffa. "We're looking forward to commencing the study later this year and sharing our results."
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.4,5 More than 30 million American adults have migraine, with three times more women than men affected by migraine.6 Migraine is often incapacitating, leading to high personal, societal and economic burden. According to the
For over 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
Emgality® is a registered trademark owned or licensed by
- Emgality [Prescribing Information].
Indianapolis, IN: Lilly USA, LLC.
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- 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. National trends 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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