Teva Canada announces the launch of AJOVY™ for the preventive treatment of migraine in adults
Thursday, April 30, 2020 4:16:00 PM
- Teva Canada announces the launch of AJOVY™ for the preventive treatment of migraine in adults who have at least four migraine days per month.
- AJOVYTM is the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults.
- AJOVYTM has been studied in patients with chronic or episodic migraine and was shown to significantly reduce patients' mean monthly migraine days—with some patients achieving a 50% reduction or more.
- Migraine is a prevalent neurological disorder, affecting more than 760,000 people in Canada and 1 billion worldwide. - -
Teva Canada, a subsidiary of Teva Pharmaceutical Industries Ltd., announced today that Health Canada has recently granted a notice of compliance (NOC) to AJOVYTM (fremanezumab) 225 mg solution for subcutaneous injection in a pre-filled syringe for the preventive treatment of migraine in adults who have at least four migraine days per month. AJOVYTM is a humanized monoclonal antibody (mAb) that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. AJOVYTM 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 prophylactic treatment of migraine.
Christine Poulin, general manager of Teva Canada, said: "Migraine places a significant burden on Canadians and the people they love, and I'm so pleased to be preparing the launch of this new preventive therapy that could change so many lives for the better. With the launch of AJOVYTM in Canada, patients will have more preventive treatment options than ever before—and AJOVYTM could give them greater flexibility in how they manage their condition. AJOVYTM is a major launch for Teva, and we are looking forward to making a difference for patients across the country when the product becomes available this summer."
AJOVYTM 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 days and the proportion of patients achieving at least a 50% reduction in migraine. The safety profile was also assessed in these trials.1–3
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.6,7 It is among the top 10 causes of disability worldwide and the seventh cause of years of life lost to disability.8–10 In Canada, migraine is most common in women and most common between the ages of 30 and 49.11 Migraine therefore reduces patients' quality of life, ability to work, and overall productivity right at the prime of their life. While acute treatment modalities are used to treat migraines when they occur, they do not prevent them. Novel treatments like AJOVYTM were specifically designed to actually prevent migraine from occurring.
Dr. Elizabeth Leroux, founder of the websites Migraine Québec and Migraine Canada and president of the Canadian Headache Society, said: "Migraine is both underdiagnosed and poorly treated. Part of that was due to limitations of available preventive therapies. With the launch of AJOVYTM, patients will have more choice than ever before. With more treatments comes more awareness, which means we may finally be breaking the stigma and suffering of migraine. It's a wonderful time to be working in this field, and I'm so pleased to be part of this revolutionary moment."
AJOVYTM Teva Support Solutions® Patient Support Program
AJOVYTM patients and prescribers are supported by the 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.
AJOVYTM (fremanezumab) is indicated for the preventive treatment of migraine in adults who have at least four migraine days per month. AJOVYTM is available as a 225 mg/1.5 mL single-dose injection in a pre-filled 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. AJOVYTM is intended for patient self-administration after the patient or their caretaker has been trained to administer the product.
Helping people live better days
At Teva, we care deeply about the well-being of the patients, caregivers, and communities that rely on us. We serve 200 million people every day, with a promise to help them take better control of their health. 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.
SOURCE: Teva Canada