Teva Canada announces a new autoinjector for AJOVY® for the preventive treatment of migraine in adults

AJOVY® now offers patients more flexibility with two dosing options available in an auto-injector and a pre-filled syringe

  • AJOVY® supports the AJOVY® Teva Support Solutions® (AJOVY® TSS) Patient Support Program, whose services include reimbursement, bridging / payment coverage, and injection training.

  • AJOVY® has been studied in patients with chronic or episodic migraine and has been shown to significantly reduce the average monthly migraine days in patients – in some patients who have achieved a reduction of 50% or more.1,2,3

Teva Canada, a subsidiary of Teva Pharmaceutical Industries Ltd., today announced the launch and availability of a new autoinjector for AJOVY® (fremanezumab). AJOVY® is a subcutaneous injection for the preventive treatment of migraine in adults who have at least four migraine days a month. When introduced in 2020, AJOVY® was only available in a pre-filled syringe. The product is now available in two latex-free formats1: a new auto-injector and a pre-filled syringe.

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Teva Canada announces a new autoinjector for AJOVY® (fremanezumab) for the preventive treatment of migraine in adults. (Photo: Business Wire)

AJOVY® is the first and only product in its class to be available in multiple formats, providing two unique injection devices and two optional dosing modes. It is also the first and only subcutaneous anti-CGRP (calcitonin gene-related peptide) approved in Canada, the European Union and the United States that offers quarterly (225 mg) or monthly (675 mg) dosing regimens using either an autoinjector or pre-filled syringe for preventive treatment. migraine.1,2,3 The new AJOVY® car injector also has several features that make it easy to use4 including a mechanism without pressing a button; audible signs signaling the progress of the administration; and, a window showing when the dose was delivered. In addition, the autoinjector is for single use only and locks after use.

“Migraine patients are very individual – not everyone wants the same device. At Teva Canada, we believe in the power of choice and we believe that options are important to patients and doctors,” says Christine Poulin, CEO of Teva Canada. “AJOVY® has offered flexible dosing options from the start. With the launch of this new device, AJOVY® now also offers a variety of injection options. I see AJOVY® as a complete care package, with injection training and other support provided through our AJOVY® Teva Support Solutions® ( AJOVY® TSS) Patient Support Program. “

“For many Canadians, migraine is an exhausting regular occurrence that greatly affects a patient’s ability to perform daily functions. Having another option in the AJOVY® treatment family allows patients to manage their condition according to their lifestyle,” said Dr. Elizabeth Leroux, president of the Canadian Headache Society and founder of the Migraine Quebec and Migraine Canada websites. “Recent changes in the field of migraine treatment have opened many doors; this new flexible dosing injection option opens another one for patients and healthcare providers who manage migraines.”

Migraine is a disabling chronic neurological disease that causes headaches so severe that sufferers often cannot function during an attack. Migraine reduces the quality of life and impairs the ability of migraines to perform daily activities.5.6 It is among the 10 biggest causes of disability in the world and the seventh cause of years of life lost due to disability.7,8,9 In Canada, migraines are most common in women, and most common between the ages of 30 and 49.10 Migraine therefore reduces a patient’s quality of life, work ability, and overall productivity at the very peak of their life. Although acute treatment modalities are used to treat migraine attacks when they occur, they do not prevent them. New treatments like AJOVY® are specifically designed to actually prevent migraines.

AJOVY® was studied in two key phase III clinical trials involving patients with migraine disability and studying fremanezumab as a prophylactic treatment. In patients with chronic migraine, 40.8 percent of the monthly dose and 37.6 percent of the quarterly dose experienced more than a 50 percent reduction in average monthly headache days of least moderate severity.11 In patients with episodic migraine, 47.7% taking the monthly dose and 44.4% taking the quarterly dose experienced more than a 50% reduction in the monthly average number of migraine days.12 The safety profile was also assessed.1,2,3 AJOVY® has been studied in patients with chronic or episodic migraine and has been shown to significantly reduce the average monthly migraine days in patients – in some patients who have achieved a reduction of 50% or more.1,2,3

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 single dose of 225 mg / 1.5 ml in a self-injector or pre-filled syringe with two dosing options: 225 mg per month, administered as a single subcutaneous injection; or 675 mg every three months (quarterly), given as three subcutaneous injections. AJOVY® is for self-administration of a patient after the patient or caregiver has been trained to administer the product. Patients and physicians prescribing AJOVY® are supported by the AJOVY® Teva Support Solutions® Patient Support Program.

About Teva in Canada

Toronto-based Teva Canada has been providing Canadians with affordable healthcare solutions for more than 50 years, building their trust one prescription at a time with more than 192,00013 recipes are filled daily with our products, representing 1 in every 8 generic recipes in canada.14 Originally Novopharm Limited, Teva Canada specializes in the development, production and marketing of high quality generic prescription drugs and through our branded division focuses on a diverse line of specialty and biopharmaceutical products in various therapeutic areas such as Central Nervous System (CNS), Respiratory, Oncology and rheumatological. Teva Canada’s commitment to helping improve the lives of Canadians extends to the Teva Caregiver program – providing tools and resources for Canadians moving through the care path. Teva Canada employs more than 900 professionals, sales were nearly $ 1.1 billion15 2020, and there are more than 360 on the market16 products in over 840 SKUs16 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 manufacturing drugs to improve people’s lives for more than a century. We are a global leader in generic and specialty drugs with a portfolio of over 3,500 products in almost every therapeutic area. About 200 million people worldwide take the drug Teva daily, and it is served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generic products, we have significant innovative research and operations that support our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

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CGRP: peptide linked to the calcitonin gene; SKU: Inventory storage unit

1. AJOVY® Product Monograph. Teva Canada Limited, Montreal, Quebec. December 15, 2020

2. Dodick DW et al. Effect of fremanezumab compared with placebo on the prevention of episodic migraine. JAMA. 2018; 319 (19): 1999–2008. doi: 10.1001 / January.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. Two human factor studies evaluated the evaluators’ ability to perform critical tasks to demonstrate the use of AJOVY Autoinjectors in simulated use sessions. To the question “Was the autoinjector easy to use?”, 97% in study 1 (N = 30) and 98% in study 2 (N = 47) answered “Yes”. Record Data, Parsippany, NJ Teva Pharmaceuticals USA, Inc.

5. Buse DC, Rupnow MF, Lipton RB. Assessment and management of all aspects of migraine: migraine attacks, functional impairment associated with migraine, common comorbidities, and quality of life. Mayo Clin Proc. 2009; 84: 422–435. doi: 10.1016 / S0025-6196 (11) 60561-2.

6. Lipton RB, Lieberman JN, Kolodner KB et al. Migraine headache disability and health-related quality of life: a population-based case study study from England. Cephalalgia. 2003; 23: 441-450. doi: 10.1046 / j.1468-2982.2003.00546.x.

7. Steiner TJ, Stovner LJ, Birbeck GL. Migraine: the seventh disabling. J Headache. 2013; 14: 1. doi: 10.1186 / 1129-2377-14-1.

8. Collaborators in the study of the global burden of disease. Global, regional and national incidence, prevalence and age of disability due to 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Disease Burden Study 2013. Lancet. 2015; 386: 743–800. doi: 10.1016 / S0140-6736 (15) 60692-4.

9. Institute of Metrics and Health Evaluation. Global burden of disease visualization tools. Available at: http://vizhub.healthdata.org/gbd-compare/. Retrieved January 2016.

10. Ramage-Morin PL, Gilmour H. Migraine prevalence in the Canadian household population. Health Rep. 2014; 25 (6): 10–16.
11. Adapted to the product monograph. Includes all randomized patients who received at least 1 dose of study drug and had at least 10 days of efficacy evaluation after baseline at the primary endpoint. A fixed series of (hierarchical) testing procedures were performed to control the type 1 error rate to 0.05. The p values ​​were based on the Cochran-Mantel-Haenszel test stratified with the basic preventive drug use (yes / no). Early discontinued patients were considered those who did not respond to the overall analysis. Defined as a day on which headache pain lasted ≥ 4 consecutive hours and had a peak severity of at least moderate levels or days on which acute migraine-specific medications (triptans or ergots) were used to treat headaches of any severity or duration. – Reference 2: Silberstein SD, Dodick DW, Bigal ME and others. Fremanezumab for the preventive treatment of chronic migraine. NEJM. 2017; 377 (22): 2113–2122.
12. Adapted to the product monograph. Includes all randomized patients who received at least 1 dose of study drug and had at least 10 days of efficacy evaluation after baseline at the primary endpoint. A fixed series of (hierarchical) testing procedures were performed to control the type 1 error rate to 0.05. The p values ​​were based on the Cochran-Mantel-Haenszel test stratified with the basic preventive drug use (yes / no). Early discontinued patients were considered those who did not respond to the overall analysis. Defined as a calendar day with ≥ 2 consecutive hours of headache that meet the criteria for migraine; probable migraine; or one day, regardless of duration, when acute migraine-specific medications (triptans or ergots) were used to treat the headache. – Reference 3: Dodick DW, Silberstein SD, Bigal ME, et al. Effect of fremanezumab compared with placebo on the prevention of episodic migraine. JAMA. 2018; 319 (19): 1999–2008.

13. Source: IQVIA CDH Compuscript TRx MAT December 2020

14. Source: IQVIA Compuscript Trx MAT 2020.12

15. Source: IQVIA CDH & Compuscript MAT December 2020

16. Source: Teva Price list March 2, 2021

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