Teva Pharmaceuticals has submitted a supplemental Biologics License Application to the FDA for AJOVY (fremanezumab-vfrm) to prevent episodic migraines in children and adolescents aged 6-17 weighing at least 45 kilograms. If approved, AJOVY would become the first calcitonin gene-related peptide (CGRP) antagonist available for both adult and pediatric migraine prevention. The application is supported by positive results from the Phase 3 SPACE trial, which demonstrated AJOVY’s efficacy and safety in the target pediatric population.
This potential expansion of AJOVY’s indication is particularly important due to the limited treatment options currently available for pediatric migraines. Migraines significantly impact children and adolescents, disrupting their education, social interactions, and overall well-being. An effective preventative treatment could significantly improve their quality of life and reduce the burden of this debilitating condition. Furthermore, the availability of a CGRP antagonist for younger patients could lead to earlier intervention and potentially prevent the progression of migraine from episodic to chronic forms.
The Phase 3 SPACE trial showed statistically significant reductions in monthly migraine and headache days in pediatric patients treated with AJOVY compared to placebo. The observed safety profile was consistent with that seen in adult trials. Currently, AJOVY is the only anti-CGRP treatment available in the US offering both monthly and quarterly dosing options for adults.
FDA approval of this sBLA would solidify AJOVY’s market position, potentially making it the leading CGRP antagonist by expanding access to a substantial and underserved patient population. This expansion could also encourage further research into CGRP-based therapies for pediatric neurological conditions. The availability of a safe and effective preventative treatment may also increase awareness and diagnosis of migraine in younger age groups, ultimately leading to improved management and outcomes for pediatric migraine sufferers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
