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
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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.
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
"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.
"We are proud to bring this important advancement to pediatric migraine care in
About
Pr
AJOVY®
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
Cautionary Note Regarding Forward
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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. |
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