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

TORONTO, Oct. 2, 2019 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce the availability of Emgality™ (galcanezumab) in Canada. Emgality is indicated for the prevention of migraine in adults who have at least 4 migraine days per month.¹

Migraine is a complex neurological disease that has a crippling effect² on the lives of nearly three million Canadians,³ and globally migraine was the second leading cause of disability in 2016.⁴ Living with migraine results in collateral damage on all aspects of life – its debilitating physical effects impact work, social life, relationships and mental well-being.⁵

"Every day in the clinic I meet people who suffer with debilitating migraines that impact their quality of life. Migraine-specific medications that work to prevent and ultimately reduce migraine days are needed to treat this disease," says Dr. Elizabeth Leroux, Headache Neurologist in Montreal and President of the Canadian Headache Society. "Clinical data show that treatment with Emgality may significantly reduce migraine days for these patients. This is good news." 

"Migraine is a complex disease that impacts patients in many different ways. The research on CGRP has led to a new class of migraine preventives for Canadians living with episodic and chronic migraine," said Jillian Reardon, Secretary of Migraine Canada and pharmacist in British Columbia.  "CGRP antibodies may help those who need relief from the pain and associated symptoms of migraine. Migraine Canada welcomes new treatments, like galcanezumab, that may improve the lives of Canadians with migraine."

About Emgality

Emgality, specifically designed to prevent migraine, is a humanized monoclonal antibody that selectively binds to the calcitonin gene-related peptide (CGRP) and inhibits its biological activity.¹ Taken once monthly, the recommended initial (loading) dose of Emgality is 240 mg (administered as two injections), followed by once monthly doses of 120 mg (one injection) delivered via subcutaneous injection.¹

The auto injector device used to administer Emgality was designed with patients in mind: it is ready to use and comes with a pre-attached hidden needle. Patients don't need to see or handle the needle, making for an easier injection experience.⁶ 

About the research behind Emgality¹
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).

In all three trials, patients were randomized to receive once-monthly placebo, Emgality 120 mg after an initial loading dose of 240 mg, or Emgality 240 mg. The primary endpoint was the mean change from baseline in the number of monthly MHDs over the double-blind treatment period in the intent-to-treat study population.

EVOLVE-1⁷ (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.2, placebo 9.1)

• 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)

EVOLVE-2⁷ (Over Months 1 to 6 - baseline migraine headache days: Emgality 9.1, placebo 9.2)

• 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)

REGAIN⁸ (Over Months 1 to 3 - baseline migraine headache days: Emgality 19.4, placebo 19.6)

• 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)

In the three integrated pivotal migraine placebo-controlled study periods, injection site pain was the most frequently (≥10%) reported adverse event. In most patients, reported injection site pain occurred within site reactions were reported within one day, and most resolved within a few days. Most events were mild to moderate and did not lead to discontinuation of Emgality.¹

For full prescribing information, including Patient Information, please refer to the Canadian Product Monograph for Emgality, available at www.lilly.ca.

About Eli Lilly Canada Inc. 
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 Effects 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

SOURCE Eli Lilly Canada

For further information: Media Contact: Loren Dingwall, Proof Inc., [email protected], 416-969-2749