MONTRÉAL, Québec--(BUSINESS WIRE)-- Teva Canada Limited a subsidiary of Teva Pharmaceutical Industries Ltd., today announced product availability of AJOVY™ (fremanezumab) 225 mg solution for subcutaneous injection for the preventive treatment of migraine in adults who have at least four migraine days per month. AJOVY™ is the first and only anti-CGRP drug approved in Canada, the European Union, and the United States that offers quarterly or monthly dosing regimens for the preventive treatment of migraine. The quarterly dose of 675 mg is given as three 225 mg subcutaneous injections once every three months; the monthly dose of 225 mg is given as one subcutaneous injection once each month. AJOVY™ is currently available in a latex-free prefilled syringe. ^1–3

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Teva Canada announces product availability of AJOVY™ (fremanezumab) (Photo: Business Wire)

“Canadian patients and prescribers have been waiting for a product like AJOVY™ that offers flexible dosing options convenient for their busy lifestyles,” says Christine Poulin, General Manager of Teva Canada. “With the product now in distribution across Canada, Teva Canada is also introducing a comprehensive patient support program to educate patients and provide financial support to meet the various needs of Canadians who suffer with the condition.”

Migraine is a disabling chronic neurological disease that causes head pain so severe that sufferers often cannot function during an attack. Migraine reduces quality of life and disrupts migraineurs’ ability to perform daily activities.^4,5 It is among the top 10 causes of disability worldwide and the seventh cause of years of life lost to disability.^6–8 In Canada, migraine is most common in women and most common between the ages of 30 and 49.⁹

Dr. Elizabeth Leroux, president of the Canadian Headache Society and founder of the websites Migraine Quebec and Migraine Canada, says the availability of AJOVY™ is good news for all migraine patients and treaters. “The unique dosing options that AJOVY™ offers will provide added flexibility and stability for many patients to manage their symptoms with less disruption to their lives and routines. This is a welcome next step in migraine management.”

AJOVY™ was evaluated in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylactic treatment. In these trials, efficacy assessments included the change from baseline in the number of average monthly migraine or headache days and the proportion of patients achieving at least a 50% reduction in affected days. The safety profile was also assessed in these trials.^1–3

About the AJOVY™ Teva Support Solutions® (AJOVY TSS) Patient Support Program

AJOVY™ patients and prescribers are supported by the AJOVY™ Teva Support Solutions® Patient Support Program, which was developed in collaboration with Canadian migraine experts and offers services such as injection training, insurance/coverage investigation, and paperwork assistance.

About AJOVY™

AJOVY™ (fremanezumab) is indicated for the preventive treatment of migraine in adults who have at least four migraine days per month. AJOVY™ is available as a 225 mg/1.5 mL single-dose injection in a prefilled syringe with two dosing options: 225 mg monthly, administered as one subcutaneous injection; or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY™ is intended for patient self-administration after the patient or their caretaker has been trained to administer the product.

Helping improve the lives of Canadians

At Teva, we are committed to providing innovative and quality medicines to the nearly 200 million people we serve around the world every day. From our role as a global leader in generic and brand name medicines to the innovative solutions we create for our healthcare partners, we offer a unique perspective on health—here in Canada and around the world.

About Teva Canada

Teva Canada, headquartered in Toronto, has provided affordable healthcare solutions to Canadians for over 50 years, building their trust one prescription at a time with now more than 217,000¹⁰ prescriptions filled each day with our products. Originally Novopharm Limited, Teva Canada specializes in the development, production, and marketing of high-quality generic prescription pharmaceuticals and, through our branded division, focuses on a diverse line of innovative products in a variety of therapeutic areas. Teva Canada employs more than 900 professionals, had sales of nearly $1.3 billion¹⁰ in 2019, and markets more than 385 products in 1,000 SKUs¹⁰ in Canada. We are a proud subsidiary of Teva Pharmaceutical Industries Ltd. Learn more at www.tevacanada.com.

About Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

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CGRP: calcitonin gene-related peptide; SKU: Stock Keeping Unit

1. AJOVY™ Product Monograph. Teva Canada Limited, Montréal, Quebec. April 9, 2020.
2. Dodick DW et al. Effect of fremanezumab compared with placebo for prevention of episodic migraine. JAMA. 2018;319(19):1999–2008. doi: 10.1001/jama.2018.4853.
3. Silberstein SD et al. Fremanezumab for the preventive treatment of chronic migraine. N Engl J Med. 2017;377(22):2113–2122. doi: 10.1056/NEJMoa1709038.
4. Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84:422–435. doi: 10.1016/S0025-6196(11)60561-2.
5. Lipton RB, Liberman JN, Kolodner KB, et al. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003;23:441–450. doi: 10.1046/j.1468-2982.2003.00546.x.
6. Steiner TJ, Stovner LJ, Birbeck GL. Migraine: the seventh disabler. J Headache Pain. 2013;14:1. doi: 10.1186/1129-2377-14-1.
7. Global Burden of Disease Study Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743–800. doi: 10.1016/S0140-6736(15)60692-4.
8. Institute for Health Metrics and Evaluation. Global burden of disease visualization tools. Available from: http://vizhub.healthdata.org/gbd-compare/. Accessed January 2016.
9. Ramage-Morin PL, Gilmour H. Prevalence of migraine in the Canadian household population. Health Rep. 2014;25(6):10–16.
10. Source: IQVIA CDH & Compuscript MAT. April 2020.

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