Emgality® (galcanezumab) now approved for use in Canada for the treatment of episodic cluster headache

The first and only anti-CGRP treatment with dual indications

TORONTO, Feb. 25, 2021 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce that Emgality® (galcanezumab) is now indicated for the reduction in the frequency of attacks throughout a cluster period in adults with episodic cluster headache with prior cluster headache periods lasting at least 6 weeks and who have had an inadequate response to, or tolerated poorly, or had contraindications to conventional preventive therapies established by Canadian practice guidelines. ⁱ

This is the second indication for Emgality, making it the first and only calcitonin gene-related peptide (CGRP) binding monoclonal antibody approved in Canada to reduce the frequency of episodic cluster headache attacks that is also approved for the prevention of migraine in adults who have at least 4 migraine days per month.ⁱⁱ 

"This is good news for patients living with episodic cluster headache who have had an inadequate response to conventional preventive therapies. Cluster headache attacks are the worst pain known to humanity. Enduring many of these attacks every day, often waking you from sleep, is extremely disruptive. A new treatment that could rapidly decrease the frequency of attacks would be life-changing," says Dr. Elizabeth Leroux, Headache Neurologist in Montreal and President of the Canadian Headache Society. "The approval provides physicians with an additional treatment option to help these patients who suffer from extreme pain." 

Episodic cluster headache is a devastating primary headache disorder characterized by the abrupt onset of attacks of severe- to very severe pain on one side of the head, occurring in cluster periods lasting typically two weeks to three months.ⁱⁱⁱ 

Most patients (90%) with cluster headache suffer from the episodic form, meaning they have remissions (with no attacks) of more than 3 months and the cluster periods do not last more than 1 year.^iv Pain is felt around or above the eye and/or temple and can be accompanied by symptoms on the same side of the body: eye redness, tearing, nasal congestion, runny nose, forehead and facial sweating, constriction of the pupil, drooping eyelid and/or swollen eyelid, and/or restlessness or agitation.^v These attacks last 15 to 180 minutes when untreated and can occur from once every other day to eight times per day.^vi 

Cluster headaches can be so painful that sufferers are unable to follow their normal routine and activities.^vii While episodic cluster headache is not as common as migraine, it does impair life for thousands of Canadians.^viii About 1 in 1,000 adults have episodic cluster headache, with men affected 3:1 compared to women.^ix 

About Emgality^x
Emgality is a humanized IgG4 monoclonal antibody that binds calcitonin gene-related peptide (CGRP) and prevents its biological activity. Emgality targets CGRP with high affinity (KD = 31 pM) and does not bind to the CGRP receptor or related peptides adrenomedullin, amylin, calcitonin and intermedin.

Emgality is administered subcutaneously through a single-use prefilled syringe or a prefilled pen and is intended for patient self-administration. 

• For the prevention of migraine, Emgality is available in pre-filled syringes and prefilled pens.^xi
• For episodic cluster headache, Emgality is available in 100 mg/mL prefilled syringes.

The recommended dose of Emgality for episodic cluster headache is 300 mg once a month (administered as three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Treatment benefit should be assessed within 3 weeks of the initiation of treatment. In patients with no improvement within this time, any further decisions for continuation of the treatment should be carefully considered based on individual patient basis and clinical judgement.^xii

The science of Emgality for episodic cluster headache^xiii
The safety and efficacy of Emgality (300 mg once a month) for episodic cluster headache was evaluated in adult patients with episodic cluster headache in a placebo-controlled clinical trial that included 106 patients.

CGAL was a randomized, multicenter double-blind placebo-controlled study in adults who met diagnostic criteria for episodic cluster headache and had a prior history of a cluster period lasting 6 weeks or longer.

In CGAL, patients were randomized at the initiation of phase 3 (1:1) to receive subcutaneous injections of either Emgality 300 mg once a month or placebo once a month, over an 8-week treatment period.

During the prospective 7-day baseline assessment, patients were required to have a maximum of 8 attacks per day, a minimum of one attack every other day, and at least 4 attacks.

The primary efficacy endpoint was the mean change from baseline in weekly cluster headache attack frequency across Weeks 1 to 3, with baseline defined as 7 consecutive days from the daily ePRO diary during the prospective baseline assessment.

The key secondary endpoint was the proportion of patients achieving response (defined as a reduction from baseline of 50% or greater in the weekly cluster headache attack frequency) at Week 3. The primary endpoint (Weeks 1-3) and gated secondary endpoint (at Week 3) of Study CGAL measured the effect of only one dose of Emgality.

• In the CGAL study^xiv the prospective baseline weekly frequency of episodic cluster attacks was 17.8 for participants who received Emgality 300 mg, and 17.3 for patients who received placebo. The patients who received Emgality experienced a mean reduction from baseline in the weekly frequency of their cluster headache attacks of -8.7 (N=49) versus -5.2 (N=57) in patients receiving placebo. More than two thirds of patients achieved at least a 50% reduction in the frequency of their weekly cluster headache attacks at week 3: 71.4% (N=49) for Emgality 300 mg compared to 52.6% (N=57) for placebo.

In the CGAL study, injection site pain was the most frequently reported adverse event (8%). The majority of injection site reactions, including pain, were reported within 1 day and most resolved within a few days. Most events were mild to moderate and did not lead to discontinuation of Emgality.

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

About Lilly Canada
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. 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 Lilly Canada, please visit us at www.lilly.ca.

For our perspective on issues in healthcare and innovation, follow us on Twitter @LillyPadCA

Lilly Cautionary Statement Regarding Forward-Looking Statements 
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Emgality (galcanezumab) as a treatment for patients with episodic cluster headache and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug development and commercialization. Among other things, there can be no guarantee that Emgality will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

References

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i	Emgality Product Monograph. September 17, 2020.
ii	Emgality Product Monograph. September 17, 2020.
iii	Website The International Classification of Headache Disorders 3rd edition. https://ichd-3.org/3-trigeminal-autonomic-cephalalgias/3/ (Accessed August 6, 2019).
iv	Migraine Canada. Cluster headache: the basics. https://migrainecanada.org/posts/the-migraine-tree/roots/other-headaches/cluster-headache-basics/#:~:text=Most%20patients%20(90%25)%20with,cluster%2C%20with%20almost%20no%20remissions. Last accessed January 14, 2021.
v	Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211.
vi	Burish M. Cluster headache and other trigeminal autonomic cephalalgias. Continuum (Minneap Minn). 2018;24(4):1137-1156.
vii	HealthLinkBC. Cluster Headaches. https://www.healthlinkbc.ca/health-topics/hw186774 Last accessed January 14, 2021.
viii	Migraine Canada. Canadian clusterbusters: time to unite. https://migrainecanada.org/posts/news/canadian-clusterbusters-time-to-unite/ Last accessed January 14, 2021.
ix	IHS Classification Committee Cephalagia. 2018;38(1):1-211.
x	Emgality Product Monograph. September 17, 2020.
xi	Emgality Device SF Training Playbook.
xii	Emgality Product Monograph. September 17, 2020
xiii	Emgality Product Monograph. September 17, 2020.
xiv	Emgality Product Monograph. September 17, 2020.

SOURCE Eli Lilly Canada

Media Contact: Helen Stone, Lilly Canada, [email protected], 416-693-3169; Loren Dingwall, Proof Strategies Inc., [email protected], 416-969-2749