Results From Phase III SPACE Trial of AJOVY Show Promise in Episodic Migraine Prevention
Study met its primary endpoint with statistically significant superior efficacy over 12 weeks of treatment compared to placebo.
Teva Pharmaceuticals has shared new results from the Phase III SPACE clinical trial (NCT03539393) evaluating the efficacy of AJOVY (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years. Results were positive with the study meeting its primary endpoint with AJOVY achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo.1
The Phase III SPACE trial, sponsored by Teva, is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study.2 It evaluated the subcutaneous administration of fremanezumab versus placebo over a 12 week period for the preventive treatment of episodic migraine in 235 pediatric patients.
According to Teva, data from this trial are the first Phase III study evidence of safety and efficacy of an anti-CGRP monoclonal antibody for the treatment of migraine in a pediatric population. Additionally, safety data from the trial was consistent with that observed in adult populations, with no emergent safety signals. Teva plans to share the full data at a medical conference later in 2024.
"The study outcome is excellent news in light of the unmet need for effective preventive therapies for children and adolescents living with migraine who are greatly impacted by this debilitating disease,” Eric A. Hughes, MD, PhD, executive vice president, global R&D and chief medical officer at Teva Pharmaceuticals said in a press release. "The SPACE data supports our ambitions to bring the proven benefits of AJOVY to children and adolescent patients who have fewer treatment options available to them. I am pleased to see that AJOVY is continuing to demonstrate its efficacy and safety in different migraine populations, including pediatric patients.”
According to a 2020 review published in Developmental Medicine & Child Neurology, migraine is the most common acute and recurrent headache syndrome in children.3
“This condition has unique clinical characteristics in the pediatric population, that can evolve with age, and significantly impact a child's quality of life, affecting their education, socialization, and family life,” the review authors wrote.
In September 2022, Teva shared data from two studies in which fremanezumab was found to be an effective treatment for patients with migraine who experience associated depression and anxiety. In both studies, quarterly and monthly dosing of fremanezumab demonstrated efficacy in reducing monthly migraine attacks by more than 50% compared to placebo.4
“Teva is strongly committed to supporting further research into the role of fremanezumab in managing the full spectrum of migraine patients, including those who suffer from co-morbid depression and anxiety. We see this as an important step towards a much needed personalized treatment approach for people suffering from migraine in the future,” Dieter Schultewolter, MD, vice president of global medical affairs neuroscience at Teva said in an earlier press release.
References
1. Teva Announces First Phase 3 Evidence of Efficacy and Safety of an Anti-CGRP Monoclonal Antibody in Children in AJOVY® (fremanezumab) SPACE Trial for Prevention of Episodic Migraine. News release. Teva. July 18, 2024. Accessed July 19, 2024. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-first-phase-3-evidence-of-efficacy-and-safety-of-an-anti-cgrp-monoclonal-antibody-in-child/
2. Fremanezumab Compassionate Use Program for Pediatric Patients. ClinicalTrials.gov. Accessed July 19, 2024. https://www.clinicaltrials.gov/study/NCT03539393?term=fremanezumab%20space&rank=1
3. Youssef PE, Mack KJ. Episodic and chronic migraine in children. Dev Med Child Neurol. 2020 Jan;62(1):34-41. doi: 10.1111/dmcn.14338. Epub 2019 Aug 28. PMID: 31463934.
4. Studies Show Effectiveness of AJOVY®▼ (fremanezumab) for Treatment of Migraine in Patients With Co-morbid Depression. News release. Teva. September 8, 2022. Accessed July 19, 2024. https://www.tevapharm.com/news-and-media/latest-news/studies-show-effectiveness-of-ajovy-fremanezumab-for-treatment-of-migraine-in-patients-with-co-morbid
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