SILVER SPRING, Maryland: The U.S. Food and Drug Administration has approved Teva Pharmaceuticals’ Ajovy for use in children, marking the first time a migraine prevention drug has been cleared for pediatric patients.

Ajovy, an injectable treatment already approved for adults, can now be used in children aged six and older who weigh at least 45 kilograms (about 99 pounds), the FDA said this week. The medication is administered once a month.

This expanded approval offers a new option for families of children suffering from episodic migraines—severe, recurring headaches that occur frequently enough to disrupt daily life but not on a daily basis. In children, these headaches are often accompanied by nausea, fatigue, and sensitivity to light and sound.

Ajovy belongs to a class of medications known as CGRP (calcitonin gene-related peptide) inhibitors, which work by blocking a protein associated with triggering migraines. The drug was first approved in 2018 for adult use and now joins its rivals, Amgen’s Aimovig and Eli Lilly’s Emgality, in the pediatric space. However, Ajovy is the first among them to secure FDA approval for migraine prevention in children.

In clinical trials, the most common side effects in children were pain and redness at the injection site. The FDA noted that the overall safety profile in pediatric patients was similar to that seen in adult studies. More serious but less common side effects include rash, itchiness, and hypersensitivity to the drug.

Migraine is one of the most common neurological conditions in children and adolescents, and options for prevention have long been limited. Pediatric neurologists have often relied on off-label prescriptions of adult medications or lifestyle adjustments to manage the condition.

The FDA’s approval of Ajovy for children could help shift that treatment landscape.

Ajovy’s pediatric approval also strengthens Teva’s position in the competitive CGRP inhibitor market. While Amgen’s Aimovig and Lilly’s Emgality have gained traction among adult patients.