Ajovy Approved for Pediatric Episodic Migraine Prevention

The Food and Drug Administration (FDA) has approved Ajovy^® (fremanezumab-vfrm) for the preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years weighing at least 45kg. 

Fremanezumab is a calcitonin gene-related peptide antagonist. It was originally approved in 2018 as a preventive treatment of migraine in adults. 

The sBLA for the pediatric indication is supported by data from the randomized, double-blind, placebo-controlled, phase 3 SPACE trial (ClinicalTrials.gov Identifier: NCT04458857), which enrolled patients aged 6 to 17 years with episodic migraine (<15 headache days/month). Study participants were randomly assigned to receive fremanezumab subcutaneously once monthly for 3 months, or placebo.

A total of 225 patients completed the 3-month, double-blind, treatment period. Findings showed that compared with placebo, treatment with fremanezumab led to a significantly greater reduction in monthly migraine days (primary endpoint; -2.5 vs -1.4; difference, -1.0;  P =.021), monthly headache days of at least moderate severity (secondary endpoint; -2.6 vs -1.5; difference, -1.1; P =.017), and monthly acute headache medication days (secondary endpoint; -2.1 vs -1.0; difference, -1.1; P =.002) over the 12-week treatment period. 

Additionally, more patients in the fremanezumab group achieved at least a 50% reduction in monthly migraine days compared with those in the placebo group (secondary endpoint; 47.2% vs 27%; difference, 20.2%; P =.002). 

No new safety signals were observed in the pediatric trial. The most common adverse reactions observed were injection site reactions.

Ajovy is supplied in both a single-dose prefilled autoinjector and prefilled syringe. It is administered as a subcutaneous (SC) injection either by a health care professional, a caregiver, or a patient aged 13 years and older after proper training. For pediatric patients aged 6 to 12 years, Ajovy must be administered by a health care provider or an adult caregiver.

The recommended dosage for pediatric patients aged 6 to 17 years weighing at least 45kg is 225mg SC monthly. Ajovy is not approved for children weighing less than 45kg because of the lack of an appropriate strength presentation.

This article originally appeared on MPR