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Aimovig™ (erenumab), a novel treatment developed specifically for migraine prevention receives Health Canada approval(i)

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Aimovig™ (erenumab), a novel treatment developed specifically for migraine prevention receives Health Canada approval(i)

Canada NewsWire

  • Aimovig™ is the first treatment approved in Canada to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R)i, which plays a critical role in migraineii
  • AimovigTM consistently shown to reduce monthly migraine days, with many patients achieving a 50% reduction or morei
  • Migraine is a debilitating neurological diseaseiii that profoundly impacts almost three million Canadiansiv

DORVAL, QC, Aug. 2, 2018 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Health Canada has approved Aimovig™ (erenumab) for the prevention of migraine in adults who have at least four migraine days per monthi. Migraine is a debilitating neurological diseaseiii that affects almost three million Canadiansiv. It is associated with a substantial social and economic impactv and considered the third most prevalent illness in the worldiii.

Aimovig™ was developed with a novel therapeutic approach – it is the first treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor (CGRP-R) which plays a critical role in migraineii. The treatment is designed to be self-administered as a once monthly injection and will be available in an autoinjector (SureClick®) formati.

"Migraine takes a tremendous toll on peoples' lives. We know that globally, migraine was reported as the second leading cause of years lived with disability in 2016vi," said Janice Murray, President, Novartis Pharmaceuticals Canada Inc. "What patients are looking for is effective prevention from the grip of the disease. Novartis is very proud to bring this new type of treatment to migraine sufferers. This is part of our ongoing commitment at Novartis to reimagine medicine and improve the well-being of Canadians."

The Health Canada approval of Aimovig™ is based on the results of two pivotal studies across the spectrum of chronic and episodic migraine:

  • Results of the Phase III STRIVE study of erenumab versus placebo in the prevention of episodic migraine which was published in November 2017 in The New England Journal of Medicine. The study enrolled 955 patients, including patients from five centres in Canadavii.
  • Results from a pivotal Phase II randomised, double-blind, placebo-controlled, multicentre study evaluating the efficacy of erenumab for preventive treatment of chronic migraine in adults, defined as 15 or more headache days per month of which eight or more were migraine days. This study was published in June 2017 in The Lancet Neurologyviii.

Quotes from medical experts across Canada:

"Clinicians across Canada see the tremendous impact of migraine on patients and their families. Patients are disabled and often stigmatized. Currently available options are insufficient. With Aimovig™ we now have a therapy that targets the CGRP-R pathway which is a novel approach to preventing migraine."

Dr. Elizabeth Leroux, Leader, Headache Program, and Clinical Associate Professor, Hotchkiss Brain Institute, Calgary, Alberta, and Vice President of the Canadian Headache Society

"The availability of a new therapy to prevent migraine offers new hope to patients that, at last, they might have more control over their lives. For many, going through a migraine attack can be completely incapacitating. Constantly having to live with the threat of a migraine at any given moment is destabilizing. I look forward to seeing the impact Aimovig™ will have in the management of migraine with my patients."

Dr. Heather Pim, Associate Clinical Professor of Neurology, University of Montreal, Director of the Headache Clinic at the University of Montreal Hospital Centre, and President of Migraine Quebec

"For some migraineurs, attacks can leave people unable to work or take part in activities, sometimes for days at a time. The unpredictability of not knowing when and how long a migraine will last can have a severe impact on one's career, family and personal life. Migraine is extremely common, and if we can prevent several days of headache-associated disability every month, then we can make a significant difference."

Dr. Christine Lay, Neurologist and Director of the Centre for Headache at the University of Toronto

"Migraine should not be confused with headaches. It's important for people to understand that it is a serious neurological disease that is very common. It robs people of their ability to be fully productive members of society. The arrival of this treatment is a tremendous step forward in the treatment and management of migraine."

Dr. A. Laine Green, Neurologist, Department of Medicine, Division of Neurology, Dalhousie University, QEII Health Sciences Centre, Halifax, Nova Scotia

Novartis Pharmaceuticals Canada Inc. is working to finalize the timing of product availability of Aimovig™ in Canada.

About migraine
Migraine is a chronic neurological disease that causes recurrent attacks of head pain that is often associated with nausea and vomiting and can involve sensitivity to light and soundix.
Migraine causes significant disability, seven million workdays are reportedly lost to it annually, which is likely under-reported. Most sufferers develop their first migraine headache in adolescence or early adulthoodx. The highest prevalence rates in Canada are among people in their 30s and 40s and women are more than twice as likely as men to report having migraine. People with migraine are much more likely to suffer from depression. It is a disease that impacts many areas of daily living, including education, work, sleep and drivingiv.

About Amgen and Novartis Neuroscience Collaboration
In August 2015, Amgen entered into a global collaboration with Novartis to jointly develop and commercialize pioneering treatments in the field of migraine and Alzheimer's disease (AD). The collaboration focuses on investigational Amgen drugs in the migraine field, including erenumab (Biologics License Application submitted to U.S. FDA in May 2017) and AMG 301 (currently in Phase 1 development). In April 2017, the collaboration was expanded to include co-commercialization of erenumab in the U.S. For the migraine program, Amgen retains exclusive rights in Japan, and Novartis has exclusive rights in Europe, Canada and rest of world. Also, the companies are collaborating in the development and commercialization of a beta-secretase 1 (BACE) inhibitor program in AD. The oral therapy CNP520 (currently in Phase 3 for AD) is the lead molecule and further compounds from both companies' pre-clinical BACE inhibitor programs may be considered as follow-on molecules.

About Novartis Pharmaceuticals Canada
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2017, the company invested $51 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Aimovig is a trademark of Amgen Inc. used under license by Novartis Pharmaceuticals Canada Inc.

References

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i Novartis Pharmaceuticals Canada Inc., Aimovig™ Product Monograph, July 30, 2018.

ii Goadsby PJ et al., Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132, p. 2124.

iii Migraine Research Foundation, About Migraine, accessed July 2018 at: https://migraineresearchfoundation.org/about-migraine/migraine-facts/  

iv 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 July 2018, at: https://www150.statcan.gc.ca/n1/en/pub/82-003-x/2014006/article/14033-eng.pdf?st=d31EMlsg 

v Canadian Headache Society Guideline: Acute Drug Therapy for Migraine Headache. Can J Neurol Sci. 2013; 40: Suppl. 3 - S1-S80. 

vi 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 2016. Lancet. 2017; 390:1211–1259.

vii ClinicalTrials.gov. Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention (STRIVE). Study Locations, accessed July 2018, at: https://clinicaltrials.gov/ct2/show/study/NCT02456740?show_locs=Y#locn

viii Tepper S et al., Safety and efficacy of erenumab for preventive treatment of chronic migraine: a randomised, double-blind, placebo-controlled phase 2 trial. Lancet Neurol 2017; 16: 425–34.

ix Canadian Headache Society, What is Migraine? Accessed July 2018, at: https://migrainecanada.org/2015/01/11/what-is-migraine/

x The Ontario Migraine Clinic, What is Migraine? Accessed July 2018, at: http://www.migraineclinic.ca/migraines.html

SOURCE Novartis Pharmaceuticals Canada Inc.

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