Emgality Prevents Migraine Attacks
`
`
`
`Full Product Information
`including Boxed Warning
`and Medication Guide
`
`*Data on File.
`
`Home > Survive > Treatment >
`
`For adults with Chronic Migraine, 15 or more headach
`days a month, each lasting 4 hours or more. It is not
`approved for 14 or fewer headache days a month.
`IMPORTANT SAFETY INFORMATION
`
` NEWS
`EMGALITY APPROVAL BRINGS NEW HOPE FOR PREVENTING
`MIGRAINES
`Posted by Angie Glaser | Nov 20, 2018 | 37
`
`
`
`EMGALITY IS APPROVED IN US, EU FOR MIGRAINE PREVENTION.
`NEXT UP: CLUSTER HEADACHES?
`For adults with Chronic Migraine, 15 or more headache days a m
`Updated November 20, 2018
`each lasting 4 hours or more. It is not approved for 14 or fewer
`Full Product Information
`headache days a month.
`including Boxed Warning
`IMPORTANT SAFETY INFORMATION
`and Medication Guide
`new class of Migraine meds is bringing hope to the Migraine and headache community. Eli Lilly just
`announced that Emgality (galcanezumab) has been approved by the European Commission for the
`prevention of Migraine.
`
`A
`
`x
`
`x
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`Full Product Information
`including Boxed Warning
`and Medication Guide
`
`For adults with Chronic Migraine, 15 or more headache days a mon
`lasting 4 hours or more. It is not approved for 14 or fewer headache
`month.
`IMPORTANT SAFETY INFORMATION
`
`
`
`
`
`Eli Lilly also announced this week that the FDA granted a Breakthrough Therapy Designation for Emgality for its
`ability to prevent cluster headaches. The company is expected to file with the FDA by the end of the year for cluster
`headache prevention (1).
`
`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
`
`EX2205
`Eli Lilly & Co. v. Teva Pharms. Int'l GMBH
`IPR2018-01425
`
`1
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`

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`Emgality Prevents Migraine Attacks
`
`Emgality was approved by the U.S. FDA for Migraine prevention last September. Emgality targets the peptide CGRP,
`which is actively involved in Migraine pathophysiology. Emgality is the third anti-CGRP treatments to gain approval
`this year for the prevention of Migraine in adults.
`
`Aimovig, manufactured by Amgen and Novartis, was approved in May. Teva’s formulation, Ajovy, was approved in
`September. A fourth and final anti-CGRP preventative, eptinezumab, is currently being developed by Alder
`BioPharmaceuticals.
`
`Full Product Information
`including Boxed Warning
`and Medication Guide
`
`For adults with Chronic Migraine, 15 or more headache days a mon
`lasting 4 hours or more. It is not approved for 14 or fewer headache
`month.
`IMPORTANT SAFETY INFORMATION
`
`
`
`
`
`Emgality successfully reduced Migraine attacks in patients with both episodic (more than 4 days a month) and
`Chronic Migraine, even among patients who had previously tried Botox without success. Results from Phase 3 trials
`were presented at the American Headache Society Scientific Meeting in June.
`
`STUDY: EMGALITY PREVENTS EPISODIC AND CHRONIC MIGRAINE
`ATTACKS IN PATIENTS WHO FAILED BOTOX
`Phase 3 results showed that patients with Chronic Migraine who did not respond to Botox and who were treated with
`120 mg of Emgality had an average of 3.91 fewer Migraine days compared to the placebo.
`
`Those who received the larger dose, 240 mg, had 5.27 fewer Migraine days compared to placebo (2)
`
`Super-Responders. The study also
`measured the percentage of patients who
`had at least a 50% reduction in monthly
`Migraine days: 41.3% of those receiving
`120 mg and 47.5% of those receiving 240
`mg, compared to 9.4% of placebo. In this
`analysis of patients who did not respond to
`Botox, patients treated with Emgality also
`had statistically significant improvements in
`quality of life, as measured by the Migraine-
`Specific Quality of Life Questionnaire (MSQ)
`and the Patient Global Impression of
`Severity (PGI-S) rating.
`
`A Phase 3 trial for Emgality analyzed a subset of patients who did not
`respond to Botox. More than 40% of those patients had at least a 50%
`reduction in their Migraine days. Image: Storyblocs
`
`These results, including the number of
`“super-responders” who have a substantial
`reduction in disability and Migraine days, are similar to those of other anti-CGRP drugs. This Emgality study,
`however, has the unique feature of looking at patients who failed Botox. This is promising for those with Migraine who
`have tried most of the available options and are eager for new treatments, like anti-CGRP meds.
`
`Safety and Dosing
`
`Full Product Information
`including Boxed Warning
`and Medication Guide
`
`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
`
`For adults with Chronic Migraine, 15 or more headache days a m
`each lasting 4 hours or more. It is not approved for 14 or fewer
`headache days a month.
`IMPORTANT SAFETY INFORMATION
`
`2
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`

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`Emgality Prevents Migraine Attacks
`
`Summarizing the different anti-CGRP studies, Dr. Elizabeth Loder told MedPage Today,
`
`“To me, the fascinating thing is they all look quite similar. I’m sure the individual companies would
`disagree, but to me, we’re seeing pretty much across the board the same statistically significant —
`but let’s face it, modest — reductions in number of headache days.
`
`I think the message with this class of medications is that they’re very well tolerated.”
`
`However, she noted that long-term safety remains uncertain, and safety during pregnancy is still a concern (3)
`
`The recommended dose for Emgality is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a
`loading dose, followed by monthly doses of 120 mg injected subcutaneously.
`
`The safety of Emgality was evaluated in three clinical trials that included more than 2,500 patients. Hypersensitivity
`reactions (e.g., rash, urticaria and dyspnea) have been reported with Emgality in clinical studies, can occur days after
`administration and may be prolonged. The most common adverse reactions (incidence ≥2% for Emgality and at least
`2% greater than placebo) associated with Emgality treatment (120 mg vs. placebo) were injection site reactions (18%
`vs. 13%).
`
`Full Product Information including
`Boxed Warning and Medication Guide
`
`For adults with Chronic Migraine, 15 or more headache days a month, eac
`lasting 4 hours or more. It is not approved for 14 or fewer headache days a
`month.
`IMPORTANT SAFETY INFORMATION
`®
`BOTOX may cause serious side effects that can be life threatening. Get
`medical help right away if you have any of these problems any time (hours
`®
`weeks) after injection of BOTOX :
`∙
`Problems swallowing, speaking, or breathing, due to weakening of associ
`muscles, can be severe and result in loss of life. You are at highest risk if
`these problems are pre-existing before injection. Swallowing problems ma
`last for several months.
`Spread of toxin effects. The effect of botulinum toxin may affect areas aw
`
`∙
`
`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
`
`3
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`

`

`Emgality Prevents Migraine Attacks
`
`HOW TO ACCESS EMGALITY
`The Coalition for Headache and Migraine Disorders (CHAMP) released a helpful guide to navigating the financial
`assistance programs. Access it here.
`
`EMGALITY FOR CLUSTER HEADACHES: APPROVAL BY THE END OF
`THE YEAR?
`The trials also showed that Emgality reduced episodic cluster headaches, but failed to produce results for chronic
`cluster headaches. Emgality is the only anti-CGRP treatment to produce positive Phase 3 results for cluster
`headaches.
`
`The drug company is expected to file for FDA approval for cluster headache prevention by the end of this
`year.
`
`As of press time, however, Emgality is only approved for the prevention of Migraine.
`
`STUDY: EMGALITY PREVENTS EPISODIC CLUSTER HEADACHES
`The episodic cluster headache trial included a total of 106 patients with an average of 17.5 cluster headache attacks
`per week at baseline. Patients were chosen at random to receive either once-monthly galcanezumab 300mg
`administered via injection or a placebo.
`
`Results showed that the group receiving the drug saw a significant difference in the reduction of their weekly attacks
`compared with placebo. Between Weeks 1 and 3 of the two-month treatment period, those receiving Emgality
`experienced 8.7 fewer cluster headache days vs. 5.2 fewer days for placebo; (p=0.36), the primary endpoint for the
`study.
`
`Three out of four participants (76%) who were treated with the drug had at least a 50% reduction in weekly
`cluster headache attacks compared to 57% for the placebo at Week 3, the secondary endpoint. Also, 73% of
`patients treated with Emgality reported improvements based on the Patient Global Impression of Improvement (PGI-I)
`at Week 4, compared to 46% for the placebo (4)
`
`The observed safety and tolerability profile were consistent with previous studies that evaluated Emgality for the
`prevention of Migraine. As with other anti-CGRP drugs, the long-term effects and tolerability are not known.
`
`CHRONIC CLUSTER HEADACHES ARE A DIFFERENT STORY
`Chronic cluster headaches are proving difficult to treat. A competing anti-CGRP drug from Teva, Ajovy, also failed to
`prevent chronic cluster headaches. Cluster headaches, like Migraine, are not headaches at all but are a complex,
`neurological disease. The pain is debilitating and so severe they have been dubbed “suicide headaches.”
`
`In an interview last year with Migraine Again, cluster headache warrior Tyler Mann said: “I am not a suicidal person,
`and I enjoy life. But when I am in the middle of a cluster attack, suicide is a real option that I have considered. The
`pain is more than anything you can imagine.” Despite the severity of cluster headache attacks, treatment options
`remain limited and difficult to access.
`
`Emgality’s mixed results in preventing cluster headaches are bittersweet: on one hand, an effective preventative for
`clusters is incredibly valuable, but those who are most impacted by the disease are left disappointed. None of the
`anti-CGRP medications in trials have been able to prevent chronic cluster headaches.
`
`WHAT’S NEXT?
`The U.S. list price of Emgality is $575 once-monthly, or $6,900 annually. Like the other CGRP medications, part of
`
`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
`
`4
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`

`Emgality Prevents Migraine Attacks
`
`this fee is expected to be reimbursed by health insurance companies in the US.
`
`Eli Lilly expected to file for FDA approval for the prevention of cluster headaches by the end of 2018.
`
`Patients and healthcare professionals with questions about Emgality should contact The Lilly Answers Center at 1-
`800-LillyRx (1-800-545-5979) or 1-833-EMGALITY or visit www.lilly.com. Patients can also text INFO to 54559 to
`receive an injection how-to video and other helpful resources delivered straight to their phone.
`
`COMMENTS? ARE YOU EAGER TO TRY ANTI-CGRP DRUGS LIKE
`EMGALITY?
`Photo by Ravi Roshan on Unsplash
`
`FOOTNOTES
`
`1. Saganowsky, Eric. Lilly’s third-to-market Emgality nets FDA ‘breakthrough’ in cluster headache. FierceFarma. 15
`November 18. 
`
`2. AHS 2018: Lilly’s Emgality™ (galcanezumab-gnlm) Significantly Reduced Monthly Migraine Headache Days in
`Patients with Migraine Who Previously Failed BOTOX®* (onabotulinumtoxinA). Press Release. 27 June 2018.
`Investor.lilly.com 
`
`3. Liz Highleyman. Galcanezumab Offers Hope for Cluster Headache and Migraine. AHS Meeting Coverage.
`MedPageToday. 03 July 2018. 
`
`4. AHS 2018: Lilly Highlights Positive Phase 3 Results from the Largest Controlled Preventive Trial in Episodic
`Cluster Headache. Press Release. 27 June 2018. Investor.Lilly.com 
`
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`ABOUT THE AUTHOR
`
`Angie Glaser
`Angie Glaser is the Content Editor of Migraine Again and author of the blog Chronic Migraine Life. She's a twice-nominated
`WEGO Health Advocate for her insightful writing, telling patient stories, Headache on the Hill advocacy and her bold voice o
`migraine disability. She's been featured on the Migraine World Summit and advised industry leaders on patient needs. Conne
`with her on Twitter, Facebook, Instagram and on her blog.
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` 
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`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
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`Emgality Prevents Migraine Attacks
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`Bruce
`
`First, I have had migraine for 50 plus years, longest one for 21 days straight, and have failed each and every treatment available. My failed med list
`looks like a pharmacopoedia of tried drugs. Even Botox was marginally effective and that was only because I was taking Relpax to ward off the
`worst migraines frequently. I started on Emgality with amazing efficacy. Absolutely no migraines for several months. Tried Aimovig but was far less
`effective with many side effects. Back on Emgality now.
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` 2 days ago
`
`Phillip Olcese
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` 
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`Hello,
`I am on month 2 of Emgality and don’t feel any difference in term of my headache. I don’t have migraines but chronic tension headaches in my
`temples and forehead. Wondering if anyone else is taking Emgality shots for Tension headaches and has seen relief? I’ve tried everything and am
`desperate. Thanks
`
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` 2 months ago
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`Phillip Olcese
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`Does Emgality help for pressure type (tension) headache or only migraine????
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` 2 months ago
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`Cheryl Macon
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`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
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`Emgality Prevents Migraine Attacks
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`I’ ve had headaches all my life and I am 70. I have been taking Botox injections for over two years and giving myself Anjovy injections and the
`frequency of headaches is the same. I would’ to try this .
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` 3 months ago
`
`Karla
`
` 
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`I’ve had migraines for 38 yrs! NOTHING has worked. Amiovig – worse. Emgality just started – better than amiovig!! But still migraines 5 days a
`week. Praying for everyone!!
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` 4 months ago
`
`Zelda
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` 
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`BTW:Did anyone experience hair falling out from either Aimovig or Emgality? I wouldn’t know which. I’ve used both close in time. Or if it’s a
`coincidence. Or if too soon to tell.
`Topamax definitely made my hair fall out tremendously (among other horrible side effects) & I had to stop using it even tho it helped me. “Alopecia”
`is listed as a side effect of Topamax only in SMALL print after researching online or I’d never have used it! .
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` 4 months ago
`
`Katherine
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`Zelda, that is aweful. I am here just reading about the new meds that are out for migraines. I tried Topamax for a long time. I
`didn’t have hair fall out. I hope you have checked into thyroid and or other things. There are ways to help with hair loss. YouTube
`has some good info, or a good health site. Massages help me out a little bit.
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` 2 months ago
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`Zelda
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`Thanks Katherine. I did have my thyroid checked at that time. I know hair loss is a symptom of thyroid problems. But it was
`normal. I know it was the Topamax. After I weaned off it slowly-as I continued to lose more hair!!-the hair loss eventually stopped
`when that drug was out of my system. It never happened again for many years since Topamax, until I tried 4 months of AIMOVIG.
`Same kind of hair loss in clumps! Has slowed and almost stopped completely since stopping AIMOVIG months ago.
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` 2 months ago
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`Katherine
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`YW… These types of meds must not agree with your system. I feel bad for you. I sure hope you find something that helps you out.
`Not sure if you know of any epeliptic pills, some of those help, but also not sure what they would do for side effects. Health stores
`have some ideas also, that would not be hard on you, and hopefully work. Homeopathic is easy on most people too. Another thing
`that people have had luck with is higher doses of magnesium, but… need to talk with pharmacist and also
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`Emgality Prevents Migraine Attacks
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` 2 months ago
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`Katherine
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`Also COQ10, could check with pharmacist about. I am trying 300 mg of magnesium, have to be with food. Could look into it. Oh
`and biannual beats on youtube… could check it out, each body is so different, but worth a try, as if that doesn’t work, can try
`something else, and this is all natural.
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` 2 months ago
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`Zelda
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`Thanks Katherine for all those good ideas. I’m going to try the homeopathic things one at a time to see what might help. I’ve also
`heard of “binaural” beats. Is that the same thing? Going to try that too. Thanks so much again!
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` 2 months ago
`
`Katherine
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`YW ! Yes, I spelled it wrong…. And good luck with it, and if you get good results, it would be good to hear back, and others could
`also know.
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` 2 months ago
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`Amanda
`
`Zelda-Are you currently taking Emgality and still experiencing hair loss? Or was it from the Aimovig?
`
`Thank you
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` 2 months ago
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`Blanca
`
`I lost hair severely with Topomax. Doctor then refused to accept it though now it’s listed.
`I lost hair aIn clumps with Emgality. Thyroid is fine. Follow your hunch.
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` 1 month ago
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`Emgality Prevents Migraine Attacks
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`10 Signs of Dehydration to Look out for
`
`For adults with Chronic Migraine
`a month, each lasting 4 hours or
`14 or fewer headache days a mo
`IMPORTANT SAFETY INFORMA
`BOTOX® may cause serious s
`threatening. Get medical help
`of these problems any time (h
`injection of BOTOX®:
`Problems swallowing, spea
`weakening of associated mus
`result in loss of life. You are a
`
`problems are pre-existing bef
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`For adults with Chronic Migraine, 15 or more headache day
`month, each lasting 4 hours or more. It is not approved for
`or fewer headache days a month.
`IMPORTANT SAFETY INFORMATION
`BOTOX may cause serious side effects that can be lif
`threatening. Get medical help right away if you have an
`these problems any time (hours to weeks) after injectio
`BOTOX :
`Problems swallowing, speaking, or breathing, due to
`weakening of associated muscles can be severe and res
`
`report this ad
`
`® ®
`
`https://migraineagain.com/emgality-cluster-migraine/[5/23/2019 4:45:50 PM]
`
`11
`
`

`

`Emgality Prevents Migraine Attacks
`
`For adults with Chronic Migraine
`a month, each lasting 4 hours or
`14 or fewer headache days a mo
`IMPORTANT SAFETY INFORMA
`BOTOX® may cause serious s
`threatening. Get medical help
`of these problems any time (h
`injection of BOTOX®:
`Problems swallowing, spea
`weakening of associated mus
`result in loss of life. You are a
`
`problems are pre-existing bef
`
`
`
`
`
`
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`For adults with Chronic Migraine, 15 or more headache
`a month, each lasting 4 hours or more. It is not approv
`14 or fewer headache days a month.
`IMPORTANT SAFETY INFORMATION
`®
`BOTOX may cause serious side effects that can b
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