Emgality® Shows Improvement in Work Productivity and Health and Well-Being Between Attacks in Patients with Migraine and a History of Preventive Treatment Failure
"Migraine imposes a profoundly debilitating burden, including interference with work and compromises to social life, that extends beyond the duration of the attacks themselves. At
Absenteeism (unplanned absence from work), presenteeism (impairment while working), overall work productivity loss and activity impairment (non-work related) were measured using the migraine-specific Work Productivity and Activity Impairment Questionnaire (WPAI). The burden between headache attacks (interictal burden) in four key areas, including disruption at work and school, diminished family and social life, difficulty planning, and emotional difficulty, was measured using the Migraine Interictal Burden Scale (MIBS) which is a 12 point scale (categories: 0 none, 1-2 mild, 3-4 moderate and >5 severe).
Among the 462 patients randomized to Emgality (n=232) or placebo (n=230), there were statistically significant improvements in work productivity (WPAI) and reductions in overall work productivity loss for the Emgality group compared with placebo (-14.3% vs -3.5%; p<0.01). These gains in productivity appeared to be driven by statistically significant improvements in presenteeism (-12.5% vs -2.6%; p<0.01). Absenteeism was low and not significantly different between groups. Non-work-related activity impairment was also statistically significantly reduced in the Emgality group compared to placebo (-20.7% vs -8.6%; p<0.01). Results were similar in the subgroups of patients with episodic or chronic migraine.
Additionally, the average change in MIBS from a baseline of 5.5 (indicative of severe burden in the time between migraine attacks) was statistically significantly greater in patients receiving Emgality compared to placebo (-1.8 vs -0.8, respectively; p<0.0001). Among patients with episodic migraine, the most common categorization of MIBS at Month 3 was "none" for Emgality-treated patients versus "severe" for placebo-treated patients. Among patients with chronic migraine, fewer Emgality-treated patients had "severe" interictal burden per the MIBS at Month 3, with twice as many Emgality-treated patients reporting "mild" interictal burden in comparison to placebo.
"Migraine is the second leading cause of disability worldwide and one of the main causes of disability in people between 15 and 49 years old, robbing years of their lives when most people are fostering friendships, establishing their careers and caring for their family. In the
These results were presented virtually at the 6th
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
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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