Emgality® Demonstrates Reduction in Frequency, Duration, and Pain Severity in Patients with Episodic and Chronic Migraine
"Total pain burden moves beyond the current and somewhat limited approach for describing migraine pain," said Gudarz Davar, M.D., vice president, neurology development,
This post hoc analysis of Emgality versus placebo used data from three randomized, double-blind studies in patients with episodic migraine (two pooled six-month studies – EVOLVE-1 and EVOLVE-2; Emgality n=435, placebo n=872) and chronic migraine (one three-month study – REGAIN; Emgality n=273, placebo n=535). Patients reported their headache frequency, duration, and severity using an electronic diary. Monthly total pain burden was calculated as severity-weighted duration by multiplying hours of migraine recorded and pain severity (0=none, 1=mild, 2=moderate, 3=severe) for each migraine day and summing these composite measurements over the migraine days in a month.
The mean change from baseline in monthly total pain burden was compared between Emgality and placebo groups. Patients on Emgality experienced statistically fewer severity-weighted hours of pain than at baseline at each month compared with patients on placebo (p<0.0001 for each comparison). In episodic migraine, patients on Emgality experienced 68.6 fewer severity-weighted hours of pain per month on average than at baseline and compared to those on placebo who experienced 36.2 fewer hours (mean difference = 32.3 fewer hours, 95% CI: 24.2 to 40.3). In chronic migraine, patients on Emgality experienced 102.6 fewer severity-weighted hours of pain per month on average than at baseline and compared to those on placebo who experienced 44.4 fewer hours of pain than at baseline (mean difference = 58.2 severity-weighted hours, 95% CI: 37.1 to 79.3).
"The impact of migraine is profound, and individualized management goes beyond how many days per month a person experiences migraine. Total pain burden serves as a more comprehensive measure and provides a deeper understanding for us and our patients to describe their pain," said
For over 25 years,
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
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 neurologic disease characterized by recurrent episodes of moderate-to-severe headache accompanied by other symptoms including nausea, sensitivity to light and sensitivity to sound. More than 30 million American adults have migraine, with three times more women affected by migraine compared to men. 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
Kevin Hern; firstname.lastname@example.org; 317-277-1838 (Investor Relations)
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