The FDA approved fremanezumab for pediatric migraine prevention, offering a new treatment option for children and adolescents aged 6 to 17 years.
The FDA approved fremanezumab-vfrm (Ajovy; Teva Pharmaceuticals) for the preventive treatment of episodic migraine in children and adolescent patients aged 6 to 17 years who weigh 45 kg or more. With this approval, fremanezumab is the first and only calcitonin gene-related peptide antagonist that is indicated for the preventive treatment of episodic migraine in pediatric patients and migraine in adults.1
Trial Name: A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
ClinicalTrials.gov ID: NCT04458857
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Completion Date: March 13, 2024
The manufacturers estimate that 1 in 10 US children and adolescents experience migraines. Despite their prevalence, migraines in pediatric patients are often underrecognized and undertreated, leading to disrupted social activities, missed school days, and difficulty with schoolwork. Preventive treatment of migraine can help reduce the frequency of migraine attacks, helping children and adolescents to better manage the condition day-to-day.1
Fremanezumab is available in 225-mg/1.5-mL single-dose injections in prefilled autoinjectors or syringes. The treatment can be administered either at home by a patient or caregiver or in office by a health care professional. Fremanezumab is administered once a month, and because it can be administered by a patient or caregiver, it can help support adherence and reduce treatment burden for families. This indication expands on fremanezumab’s initial FDA approval in 2018.1
“Migraines are a common yet invisible condition that can severely disrupt daily life for children and adolescents, often leaving them overlooked and misunderstood,” Chris Fox, executive vice president, US commercial and innovative franchise lead, and head of global marketing business at Teva, said in a news release. “With this FDA approval, [fremanezumab] 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.”1
This expanded indication is supported by data from the SPACE trial (NCT04458857)2, a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase 3 study that assessed the efficacy, safety, and tolerability of subcutaneous administrations of fremanezumab in patients aged 6 to 17 years with episodic migraine. Patients were randomly assigned to receive either fremanezumab (n = 123)—in which 36 patients weighing less than 45 kg received 120 mg, and 87 patients weighing 45 kg or more received 225 mg—or placebo (n = 112) as a preventive treatment.2,3
SPACE’s primary end point was the mean change from baseline in the monthly average of migraine days over the 3-month period. Additionally, secondary end points included the number of patients with treatment-emergent adverse events (AEs) and changes from baseline in quality of life and disability scores. These data were presented at the 2025 American Academy of Neurology (AAN) Annual Meeting.2,3
According to the data presented at the AAN session, fremanezumab was observed to significantly reduce monthly migraine days compared with placebo (–2.5 vs –1.4; P = .0210). These effects were noticeable as early as 1 month. Specifically, a significantly higher proportion of patients achieved at least a 50% response on fremanezumab (47.2%) than those on placebo (27.0%; P = .0016) at the 3-month period, according to the speaker. Notably, benefits were similar across both age subgroups—6 to 11 years and 12 to 17 years—as well as between genders. Fremanezumab also significantly reduced the use of acute migraine medication when compared with placebo (–2.1 vs –1.0; P = .0016).3
There was an insignificant trend observed in favor of fremanezumab on the Pediatric Migraine Disability Assessment scale, with mean changes of about –21.6 and –15.3 in the fremanezumab and placebo groups, respectively. Changes from baseline to 3 months in Pediatric Quality of Life Inventory scores were considered more significant, with mean changes being about +5.7 and +6.2 in these respective groups.3
Significantly, AEs were similar between the fremanezumab groups (55%) and placebo group (49%), and there were no AEs that led to death or treatment discontinuation. Any instances of treatment discontinuation were not believed to be a result of the trial treatment, according to the speaker.3
"Pediatric migraine is a complex condition that can significantly impact a child’s daily life, from school performance to emotional well-being," Jennifer McVige, MD, MA, pediatric neurologist at the DENT Neurologic Institute, said in the news release. “Having an FDA-approved treatment like [fremanezumab] offers an important option, providing a targeted approach to preventive treatment for episodic migraine that can help reduce the frequency of attacks in younger patients and help clinicians manage this often-overlooked condition.”1
