Fremanezumab for episodic migraine prevention demonstrates positive phase 3 data
Both monthly migraine days and headache days were reduced vs placebo in patients aged 6 to 17 years.
Fremanezumab for episodic migraine prevention demonstrates positive phase 3 dataLatest revision | Image Credit: © Jan H. Andersen - © Jan H. Andersen - stock.adobe.com.
Positive phase 3 data for fremanezumab (Ajovy;Teva Pharmaceutical Industries) has been reported for the prevention of episodic migraine in children and adolescents aged 6 to 17 years, according to a press release from Teva. Results demonstrated a statistically significant efficacy compared to placebo across 12 weeks of treatment, to go along with a safety profile that was consistent with the adult population.1
Currently, fremanezumab is indicated for prophylaxis of migraine in adults who have at least 4 per month and is available as a 225 mg / 1.5 mL single dose injection via a pre-filled syringe or a pre-filled pen, in some countries.1
In the pediatric population, individuals aged 6 to 17 years were evaluated in the phase 3 SPACE study (NCT04530110), a multicenter, randomized, placebo-controlled, parallel-group trial that compared safety, efficacy, and tolerability of subcutaneous administration of fremanezumab with placebo over 12 weeks.1,2
The trial featured 237 pediatric patients who had been diagnosed with migraine for 6 months or more, with a history of less than 14 headache days per month. Participants were broken into subgroups by age; 6 to 11 years and 12 to 17 years.1
According to Teva, the estimated prevalence of migraine among children is 7.7%, increasing from 5% among those aged 5 to 10 years to approximately 15% among adolescents.1
According to study results over 3 months, fremanezumab demonstrated: a significant reduction in monthly migraine days (MMD) compared to placebo (-2.5 vs -1.4; [P = 0.0210]); a significant reduction in monthly headache days (MHD) versus placebo (-2.6 vs -1.5; [P = 0.0172]); and a significantly higher number of children who achieved a 50% response rate compared to placebo (47.2% vs 27.0%; [P = 0.0016]).1
Results also indicated that benefits were "similar in both the age subgroups and between boys and girls," stated Teva.1
“Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licensed treatments to manage this debilitating condition in children.” Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals, said in a statement.1
"We’ve already seen the benefits of [fremanezumab] in adults and the SPACE trial has confirmed that children with episodic migraine can also benefit from [fremanezumab]. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden," said Hughes.1
Regarding safety, fremanezumab was well tolerated with no safety signals. The proportion of patients who reported 1 or more adverse event was similar between the treatment arm and the placebo arm (55% vs 49%, respectively), and the proportion of patients with serious adverse events and adverse events that led to treatment discontinuation was ≤3% and ≤1% respectively, per Teva.1
"This is an important milestone for clinicians and young patients living with episodic migraine who currently have little treatment options available to them," said Patricia Pozo-Rosich, MD, PhD, in a statement. Pozo-Rosich is a lead investigator of the trial and is the head of Section Neurology Department at Vall d’Hebron Hospital and Research Institute in Barcelona, Spain.1,3
"This is the first Phase 3 trial of a CGRP-pathway treatment that has shown statistically superior efficacy with [favorable] safety and tolerability for the prevention of episodic migraine in children and adolescents," added Pozo-Rosich.1
According to the press release, Teva "continues to study the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety."1
References:
1. Teva presents positive efficacy and safety data of AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescents from phase 3 SPACE trial. Teva Pharmaceutical Industries. Press release. December 4, 2024. Accessed December 4, 2024. https://www.biospace.com/press-releases/teva-presents-positive-efficacy-and-safety-data-of-ajovy-fremanezumab-for-the-prevention-of-episodic-migraine-in-children-and-adolescents-from-phase-3-space-trial
2. A study to test if fremanezumab is effective in preventing migraine in children and adolescents. ClinicalTrials.gov. Updated December 4, 2024. Accessed December 4, 2024. https://clinicaltrials.gov/study/NCT04530110?cond=migraine&intr=fremanezumab&rank=1
3. Patricia Pozo-Rosich. International Headache Society. Biography. Accessed December 4, 2024. https://ihs-headache.org/people/patricia-pozo-rosich/
