FDA Approves Ajovy for Childhood Migraine Prevention

Teva Pharmaceuticals announced that the FDA has approved Ajovy (fremanezumab-vfrm) for the preventive treatment of episodic migraines in pediatric patients. The approval applies to children and adolescents between the ages of 6 and 17 who weigh at least 99 pounds, according to a news release issued yesterday.

Ajovy is a calcitonin gene-related peptide (CGRP) antagonist, initially approved by the FDA in 2018 for the prevention of migraines in adults. It works by targeting CGRP, a neuropeptide that plays a key role in the development of migraines. By blocking CGRP, Ajovy helps reduce the occurrence of migraine attacks. With this new approval, Ajovy becomes the first and only CGRP antagonist cleared for both episodic and pediatric migraines.

Migraine is a complex neurological disorder with no known cause. It is characterized by unpredictable attacks that can last from a few hours to several days. These attacks often come with debilitating symptoms such as nausea, vomiting, fatigue, and sensitivity to light and sound. For children, the impact can be especially disruptive—affecting not only their physical health but also their academic performance, social development, and emotional well-being.

According to the release, nearly 1 in 10 children in the United States suffers from pediatric migraine. However, the condition frequently goes undiagnosed, largely because children may struggle to articulate the nature or intensity of their symptoms. As a result, many do not receive timely or adequate treatment.

“Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being,” Jennifer McVige, M.D., MA, pediatric neurologist at the DENT Neurologic Institute, said in the news release. “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.”

Ajovy is available as a 225 mg/1.5 mL single-dose subcutaneous injection, delivered either via pre-filled syringe or autoinjector. It can be administered by a healthcare provider, caregiver, or, for patients aged 13 years and older, self-administered at home. This flexibility may be especially beneficial for families managing chronic conditions in younger children.

The approval was based on data from a multicenter, randomized, double-blind, placebo-controlled clinical trial involving 290 pediatric patients, with 235 ultimately receiving treatment. The study found that approximately 30% of patients experienced two to four fewer migraine days per month compared to placebo. This reduction in frequency can represent a significant quality-of-life improvement for pediatric patients and their families.

Safety data from the study showed that Ajovy was generally well tolerated. The most common side effects were mild injection site reactions such as pain, redness (erythema), and hardening (induration) at the site of administration. However, the drug does carry a warning for the potential development of Raynaud’s phenomenon—a condition that affects blood flow to extremities—and an increased risk of developing or worsening hypertension.

“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” Chris Fox, executive vice president and U.S. Commercial and Innovative Franchise Lead at Teva, said in the news release. “With this FDA approval, Ajovy now offers younger patients a new treatment option, addressing a long-standing gap in care and offering families added support as they navigate the challenges of this condition.”

With this expansion of its approved uses, Ajovy may help fill a significant void in pediatric neurology and migraine care—providing young patients and their caregivers with new hope and a reliable option to manage a burdensome condition, the news release says.