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# Teva Files sBLA to Expand Migraine Therapy’s Use
- URL: https://www.fdaweb.com/teva-files-sbla-to-expand-migraine-therapys-use/
- Published: 2025-04-07T12:00:00.000Z
- Updated: 2026-09-14T14:57:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158962

FDA has accepted for review a Teva Pharmaceuticals supplemental BLA for Ajovy (fremanezumab-vfrm) to expand the indication to include preventing episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kg or more. The application is based on positive results from the Phase 3 SPACE trial, which demonstrated statistically significant improvements in reducing monthly migraine days and monthly headache days compared to placebo, the company says, adding that the safety profile was consistent with that observed in the approved adult population, the original use approved in 2018.

Ajovy works by blocking a substance in the brain called [calcitonin gene-related peptide](https://www.webmd.com/migraines-headaches/cgrp-inhibitors-for-migraine?ref=fdaweb.com#:~:text=prevention%20in%20decades.%E2%80%9D-,What%20Is%20CGRP%3F,healing%2C%20and%20contributes%20to%20inflammation.) (CGRP), which is involved in headache pain and can make headaches last longer, according to the company. By blocking CGRP, Ajovy helps prevent migraines.

On the safety side, Ajovy was associated in clinical trials with hypersensitivity reactions, including rash, pruritus, drug hypersensitivity and urticaria. “Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including Ajovy, in the postmarketing setting,” Teva says.