Teva's Ajovy Gets FDA Approval for Pediatric Use

Teva Pharmaceutical has announced that the FDA has approved its migraine therapy Ajovy for children and adolescents, expanding its label to include this age group. Ajovy was originally approved for adults. The single-dose injectable is designed to prevent migraine attacks.

Teva Pharmaceutical has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) approval of its migraine therapy, Ajovy (fremanezumab-vfrm), for children and adolescents aged 6-17 years who weigh 45 kilograms (99 pounds) or more. This approval expands the drug's label to include this age group, offering a long-awaited monthly treatment option for pediatric episodic migraine prevention.

Ajovy, a calcitonin gene-related peptide (CGRP) antagonist, was originally approved for adults in 2018. With this latest approval, it becomes the first and only CGRP antagonist indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults. This marks a meaningful advancement in expanding preventive treatment options for those living with migraine, particularly in the pediatric population.

Preventative treatment with Ajovy can help reduce the frequency of migraine attacks, enabling children and adolescents to better manage their condition day-to-day. The drug is administered once a month and is available for in-office or at-home use, offering a treatment option that is intended to support adherence and reduce treatment burden for families. According to Dr. Jennifer McVige, MD, MA, Pediatric Neurologist at the DENT Neurologic Institute, "Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being. Having an FDA-approved treatment like AJOVY offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition."

The approval underscores Teva’s ongoing efforts to address neurological challenges and expand access to neuroscience therapies across age groups. This move strengthens Teva’s commitment to broadening access to its innovative therapies, with Ajovy continuing to demonstrate efficacy in addressing the underlying biology of migraine.

About Migraine
Migraine attacks cause disabling pain, nausea, vomiting, and sensitivities to light and sound, resulting in significant effects on the ability to complete daily tasks. Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance, and missed social activities [3].

About Ajovy
Ajovy is indicated for preventive treatment of migraine in adults and episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. It is available as a 225 mg/1.5 mL single dose injection in a pre-filled autoinjector or in a pre-filled syringe. Ajovy can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.

References:
[1] https://www.marketscreener.com/news/fda-approves-expanded-indication-for-ajovy-fremanezumab-vfrm-the-first-anti-cgrp-preventive-trea-ce7c5ed9dc81f225
[2] https://www.ajovy.com/globalassets/ajovy/ajovy-pi.pdf