FDA accepts sBLA to expand fremanezumab-vfrm indication | Image Credit: © Araki Illustrations - © Araki Illustrations - stock.adobe.com.

On April 7, 2025, the FDA accepted a supplemental biologics license (sBLA) application for fremanezumab-vfrm (AJOVY; Teva Pharmaceuticals), to include children and adolescent patients aged 6 to 17 years with episodic migraine, who weigh 99 lbs (45 kgs) or more.¹

If approved, fremanezumab-vfrm would be the first calcitonin gene-related peptide (CGRP) antagonist for migraine prevention in adults and episodic migraine prevention in pediatric patients. Currently, fremanezumab-vfrm is the only anti-CGRP treatment for migraine prevention in adults in the United States that is available in both quarterly and monthly dosing options, according to the announcement from Teva.

“Migraine is common among children and adolescents, often disrupting their education, social lives and overall well-being, yet treatment options remain limited,” said Eric Hughes, MD, PhD, in a statement.

Hughes is executive vice president, Global R&D and chief medical officer at Teva.

“As we work to bring the benefits of AJOVY to younger patients, we build upon its proven success in adults," said Hughes. "If approved, AJOVY could be an important step toward filling the gap in pediatric migraine care, offering a much-needed solution for this underserved population.”

Trial data

The sBLA application was based on results from the phase 3 SPACE trial (NCT) that evaluated efficacy for the prevention of episodic migraine in pediatric patients, demonstrating statistically significant improvements in monthly migraine days and those days compared to placebo, the primary endpoint of the trial.²

The safety profile demonstrated in SPACE was also consistent with the profile observed in the adult population, according to Teva.¹

The trial compared safety, efficacy, and tolerability of subcutaneous administration of fremanezumab-vfrm with placebo across a 12-week period. The trial featured 237 pediatric patients aged for the intended expanded indication.

Additional information

First approved in 2018, fremanezumab-vfrm is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or as a pre-filled pen in some countries. Currently, there are 2 dosing options available:

• 225 mg once monthly administered as 1 subcutaneous injection (monthly dosing)
• 675 mg every 3 months (quarterly dosing), which is administered as 3 subcutaneous injections

Among children and adolescents, migraine can cause significant disability, which can then lead to absence from school, impacted educational performance, and missed social activities.

There is an overall estimated prevalence of 7.7% among children, with an increas from from 5% among children aged 5 to 10 years to approximately 15% among adolescents.²

The treatment is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Reactions have included anaphylaxis and angioedema.¹

Hypertension development and worsening of pre-existing hypertension have been reported after the use of CGRP antagonists, including fremanezumab-vfrm, in the post-marketing settings, noted Teva.

In clinical trials, the most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

References:

1. Teva announced FDA filing acceptance for AJOVY® (fremanezumab) in pediatric episodic migraine prevention. Teva Pharmaceuticals. Press release. April 7, 2025. Accessed April 7, 2025. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-fda-filing-acceptance-for-ajovy-fremanezumab-in-pediatric-episodic-migraine-prevention/

2. Teva announces first phase 3 evidence of efficacy and safety of an anti-CGRP monoclonal antibody in children in AJOVY (fremanezumab) SPACE trial for prevention of episodic migraine. Teva Pharmaceuticals. Press release. July 18, 2024. Accessed April 7, 2025. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2024/Teva-Announces-First-Phase-3-Evidence-of-Efficacy-and-Safety-of-an-Anti-CGRP-Monoclonal-Antibody-in-Children-in-AJOVY-fremanezumab-SPACE-Trial-for-Prevention-of-Episodic-Migraine/default.aspx