| Eli Lilly and Company announced positive results from two late-breaking presentations highlighting Phase 3 data for EmgalityTM (galcanezumab-gnlm), an investigational treatment for the prevention of migraine and cluster headache.
Lilly also announced that the intended brand name, EmgalityTM, has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
These results will be presented on Saturday, June 30 at the American Headache Society (AHS) annual meeting in San Francisco.
Notable presentations featuring Emgality data include:
Lilly will present late-breaking Phase 3 data from the largest controlled, preventive trial conducted in episodic cluster headache. Patients with episodic cluster headache treated with Emgality (300 mg once-monthly) experienced statistically significant differences in the reduction of weekly cluster headache attacks compared to patients treated with placebo across Weeks 1 to 3 of the two-month, double-blind treatment period (-8.7 for Emgality compared to -5.2 for placebo, p=0.036), the primary endpoint of the study. Three out of four patients (76%) treated with Emgality (300 mg once-monthly) also achieved at least a 50 percent reduction in weekly cluster headache attacks compared to 57 percent for placebo at Week 3 (p=0.04), the gated secondary endpoint. The observed safety and tolerability profile was consistent with previous studies that evaluated Emgality for the prevention of migraine.
Lilly will also present results from a post-hoc analysis which demonstrated efficacy of Emgality in patients with episodic and chronic migraine who had previously failed preventive treatment with BOTOX®* (onabotulinumtoxinA). In this subgroup analysis, patients treated with both doses of Emgality (120 mg and 240 mg) who previously failed preventive treatment with BOTOX experienced a statistically significantly greater reduction in the average number of monthly migraine headache days, and a statistically significantly greater percent (at least a 50 percent) reduction in the number of migraine headache days, compared to patients treated with placebo. As previously reported in these Phase 3 studies, the most commonly-reported adverse events were injection site reactions. (*BOTOX® is a registered trademark owned by Allergan, Inc.).
Emgality is a once-monthly, self-administered calcitonin gene-related peptide (CGRP) antibody currently under review by the (FDA) for the prevention of migraine in adults. A decision is expected by the end of September 2018. Based on results from the episodic cluster headache trial, Lilly is working with regulatory agencies around the world to determine the best path forward.
Migraine is a neurological disease that affects more than 36 million Americans, with three times more women affected compared to men.1,2,3 According to the Medical Expenditures Panel Survey, total annual healthcare costs associated with migraine in the United States are estimated to be as high as $56 billion annually.4
Cluster headache is a disabling headache disorder composed of recurrent “attacks” of intense headaches on one side of the head, frequently associated with pain behind or around one eye, restlessness and agitation.5,6 Episodic cluster headache represents 85 to 90 percent of cluster headache cases.5
Learn more about Lilly’s data presentations here. |
| References: 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.. Identifying and treating migraine. American Migraine Foundation website. https://americanmigrainefoundation.org/understanding-migraine/identifying-treating-migraine/. Last accessed April 19, 2018. Raval AD, Shah A. National trends in direct health care expenditures among US adults with migraine: 2004 to 2013. Journal of Pain. 2017;57:60. Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders, 3rd edition. Cephalalgia. 2013;33(9):629-808. Matharu M, Goadsby P. Trigeminal autonomic cephalgias. Journal of Neurology, Neurosurgery, and Psychiatry. 2002;72(Suppl II):ii19-ii26. |
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