Teva Canada Announces Approval of Expanded Indication of [Pr]AJOVY® (fremanezumab solution for subcutaneous injection), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine Français
- Health Canada approves PrAJOVY® (fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg.
- PrAJOVY® increases availability across age groups as the first and only calcitonin gene-related peptide (CGRP) antagonist approved for pediatric episodic migraine prevention and migraine prevention in adults.
- This approval marks an important step in enhancing the impact of PrAJOVY® beyond adults since its Canadian approval in 2020, and underscores Teva's ongoing efforts to advance and address neurological challenges.
TORONTO, Feb. 4, 2026 /CNW/ - Teva Canada Limited (Teva Canada) announced today that Health Canada has approved an expanded indication for PrAJOVY® (fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. With this approval, PrAJOVY® becomes the first and only calcitonin gene-related peptide (CGRP) antagonist indicated for eligible pediatric patients, marking a meaningful advancement in expanding preventive treatment options for those living with migraine.
Migraine is a neurological disease that significantly impacts children and adolescents leading to missed school, reduced social participation, and wide-ranging effects on family life. With this approval, PrAJOVY® now offers a new, once-monthly preventive option to help reduce the frequency of migraine attacks for eligible pediatric patients.
"Migraine has a profound impact on children and teens, yet pediatric patients have historically had very few preventive treatment options", said Wendy Gerhart, Executive Director of Migraine Canada. "We welcome this approval as a meaningful step forward for families navigating this challenging condition. Having additional, evidence-based choices matters and may make a measurable difference in the day-to-day lives of young people living with migraine."
Health Canada's approval of this indication is based on the results of Phase 3 SPACE trial, which demonstrated that fremanezumab significantly reduced monthly migraine days and monthly headache days versus placebo over a 12–week period in pediatric patients with episodic migraine and showed a safety profile consistent with adults.1
"As an investigator in the clinical study that supported this approval, I've seen firsthand the meaningful impact fremanezumab may have for young people living with episodic migraine", said Dr. Daniela Pohl, MD, PhD, Professor of Pediatric Neurology at the Children's Hospital of Eastern Ontario. "This is an important advancement for Canadian children and adolescents who have long lacked evidence-based preventive options. Having AJOVY available to this population gives clinicians and families a targeted therapy that can help reduce migraine burden and improve day-to-day well-being.
"We are proud to bring this important advancement to pediatric migraine care in Canada," said Fabien Paquette, General Manager of Teva Canada. "This approval reflects Teva's commitment to helping patients across all stages of life, and to ensuring families have innovative therapies backed by strong clinical science. Expanding the availability of AJOVY to younger Canadians underscores our long-standing dedication to neurological health and to closing gaps in care.
About PrAJOVY®
PrAJOVY® is indicated for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg. PrAJOVY® is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. PrAJOVY® can be administered either by a healthcare professional or at home by a patient 13 years of age or older or caregiver. No starting dose is required to begin treatment.
About SPACE
SPACE is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12–week period for the preventive treatment of episodic migraine in 237 pediatric patients aged 6 to 17 years.
About Teva Canada
Teva Canada Limited, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), is proud to celebrate 60 years of serving the health of Canadians. As one of the world's largest suppliers of generic, biosimilar, and innovative medicines, we are all in for better health -- committed to delivering reliable, high-quality treatments. With facilities in Markham, Stouffville, Toronto, and Montréal, we employ over 850 people and manufacture 70% of the medicines we sell in Canada locally, reinforcing our commitment to accessibility and supporting the Canadian economy. Learn more at www.tevacanada.com.
Cautionary Note Regarding Forward–Looking Statements
This release includes forward–looking statements that are based on Teva's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These risks include regulatory, market, and commercial factors, as well as those described in Teva's publicly filed reports. Forward–looking statements speak only as of the date of this release, and Teva undertakes no obligation to update them except as required by law
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1 Hershey, A. D., Szperka, C. L., Barbanti, P., Pozo–Rosich, P., Bittigau, P., Barash, S., Bryson, J., Kessler, Y., Schwartz, Y. C., Campos, V. R., & Ning, X. (2026). Fremanezumab in Children and Adolescents with Episodic Migraine. New England Journal of Medicine. |
SOURCE Teva Canada
For more information, please contact: Stuart Shields, Director, Communications & Corporate Affairs, [email protected], Teva Canada
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