The US Food and Drug Administration (FDA) has approved a label expansion to Teva’s Ajovy in certain children and adolescents, making it the first migraine prevention drug of its kind in the age group.
Single-dose injectable Ajovy (fremanezumab-vfrm) is now approved for the preventive treatment of episodic migraine in children and adolescent patients aged between six and 17 years who weigh 45kg or more.
Ajovy is part of a class of drugs called calcitonin gene-related peptide (CGRP) inhibitors, which block a protein involved in triggering migraines.
The FDA approved Ajovy for adults in 2018. Israel-based Teva narrowly missed having the first CGRP-targeting drug approved for migraines at the time, following Novartis and Amgen’s Aimovig (erenumab) approval earlier in the year. However, the therapy is not approved for children or adolescents, meaning its patient reach is now not as wide as Ajovy.
One in ten children and adolescents in the US suffers from migraines, one of the most common neurological conditions. Paediatric migraine is often underrecognised and undertreated, disrupting lifestyle such as school attendance and social interactions. Episodic migraine refers to recurring severe headaches in children that do not occur daily but are frequent enough to interfere with daily activities.
Ajovy is administered once a month and available for in-office or at-home use, offering an accessible treatment option for patients and their caregivers, such as parents. A higher-dose version, given every three months as three injections, is also available for adults.
Teva’s Phase III SPACE trial (NCT03539393) with the drug demonstrated statistically significant superior efficacy compared to placebo over three months in the paediatric population. The safety profile was consistent with that in the adult population – the most common side effects being itchiness, rash and drug hypersensitivity.
Teva's global marketing business head Chris Fox said: “Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood.
“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.”
The label expansion in children and adolescents gives Teva an edge over Novartis/Amgen, as well as Eli Lilly, whose Emgality (galcanezumab) – also a CGRP inhibitor – is also approved and on the market.
Last year, Teva's migraine treatment Ajovy generated $507m in global sales, an 18% increase compared to the previous year. Analysis by GlobalData forecasts sales of $885m by 2031.
Neither Amgen nor Lilly disclosed specific sales for their two products in 2024.
GlobalData is the parent company of Pharmaceutical Technology.
