EMGALITY (galcanezumab) now available in Canada for preventive treatment of migraine
New anti-CGRP treatment for the prevention of migraine in adults? with at least 4 migraine days per month1
The safety and efficacy of Emgality was evaluated in clinical trials that included more than 2,500 patients. Emgality was evaluated as a preventive treatment (a treatment expected to decrease migraine headache frequency) of episodic or chronic migraine in three Phase 3 randomized, multicenter, double-blind, placebo-controlled studies in adult patients:
- EVOLVE-1 and EVOLVE-2 were randomized, 6-month, double-blind, placebo-controlled studies that enrolled adult patients with episodic migraine (defined as 4-14 migraine headache days [MHDs] per month).
- REGAIN was a randomized, 3-month, double-blind, placebo-controlled study that enrolled adult patients with chronic migraine (defined as at least 15 headache days per month with at least 8 MHDs per month).
- Mean change from baseline (days): -4.7 days (N=210) for Emgality 120 mg compared to -2.8 days (N=425) for placebo (p<0.001)
- Up to 3 in 5 patients achieved at least a 50% reduction in MHDs in any given month on average (% responders): 62% (N=210) for Emgality 120 mg compared to 39% (N=425) for placebo (p<0.001)
- More than 1 in 3 patients achieved at least a 75% reduction in MHDs in any given month on average (% responders): 39% (N=210) for Emgality 120 mg compared to 19% (N=425) for placebo (p<0.001)
- Up to 1 in 7 patients achieved a 100% reduction in monthly MHDs (p<0.001) in any given month on average (% responders): 16% (N=210) for Emgality 120 mg compared to 6% (N=425) for placebo (p<0.001)
- Mean change from baseline (days): -4.3 days (N=226) for Emgality 120 mg compared to -2.3 days (N=450) for placebo (p<0.001)
- Up to 3 in 5 patients achieved at least a 50% reduction in MHDs in any given month on average (% responders): 59% (N=226) for Emgality 120 mg compared to 36% (N=450) for placebo (p<0.001)
- More than 1 in 3 patients achieved at least a 75% reduction in MHDs in any given month on average (% responders): 34% (N=226) for Emgality 120 mg compared to 18% (N=450) for placebo (p<0.001)
- Up to 1 in 7 patients achieved a 100% reduction in MHDs in any given month on average (% responders): 12% (N=226) for Emgality 120 mg compared to 6% (N=450) for placebo (p<0.001)
- Mean change from baseline (days): -4.8 days (N=273) for Emgality 120 mg compared to -2.7 days (N=538) for placebo (p<0.001)
- At least a 50% reduction in MHDs in any given month on average (% responders): 28% (N=273) for Emgality 120 mg compared to 15% (N=538) for placebo (p<0.001)
Eli Lilly and Company is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to people who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism. Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the?University of?Toronto, which eventually produced the world's first commercially-available insulin. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Eli Lilly Canada, please visit us at?www.lilly.ca.
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1?Emgality Product Monograph. July 30, 2019 |
2?The International Classification of Headache Disorders, 3rd edition. (2018). Cephalalgia, 38(1), 1-211 |
3?Ramage-Morin, PL and Gilmour H, Prevalence of migraine in the Canadian household population, Health Reports, Vol. 25, no. 6, pp.10-16, June 2014, Statistics Canada, accessed October 2018, at:?https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2014006/article/14033-en |
4?Vos T, Abajobir AA, Abbafati C, Abbas KM, Abate KH, Abd-Allah F, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the global burden of disease study 2016Lancet. 2017; 390:1211?1259 |
5?Burden of Migraine Sufferers, MD Analytics, March 2019 |
6?Emgality Device SF Training Playbook |
7?Janet H. Ford, PhD, et al. "Two randomized migraine studies of galcanezumab E?ects on patient functioning and disability."Neurology |
8?Holland C. Detke, et al. "Galcanezumab in chronic migraine The randomized, double-blind, placebo-controlled REGAIN study."Neurology |