Teva Pharmaceuticals, the US affiliate of Teva Pharmaceutical Industries, has announced its first preventive migraine treatment for kids.
The pharma company said that the New England Journal of Medicine has published pivotal Phase 3 data confirming the efficacy and safety of AJOVY in children and adolescents with episodic migraine.
The findings, from the SPACE study, paved the way for FDA approval of AJOVY for pediatric patients aged 6-17 years weighing 45 kilograms (99 pounds) or more, making it the first and only calcitonin gene-related peptide (CGRP) antagonist approved for preventive treatment of episodic migraine in children and adolescents, as well as migraine in adults.
"With an estimated 1 in 10 children and adolescents in the US living with migraine, the need for effective preventive options is critical as this condition can disrupt daily life for patients and families," said Eric Hughes, Executive Vice President, Global R&D and Chief Medical Officer at Teva.
"The SPACE trial results published in the New England Journal of Medicine add to the growing body of evidence supporting AJOVY and build on its established use in adults. Teva is proud to be leading the charge and continuing to innovate for the migraine community."
The 3-month, randomized, placebo-controlled SPACE study enrolled 237 children and adolescents aged 6-17 years. Participants received monthly subcutaneous injections of fremanezumab (AJOVY) or placebo.
AJOVY reduced monthly migraine days (MMD) by 2.5 days compared to 1.4 days with placebo, and cut monthly headache days of at least moderate severity by 2.6 days versus 1.5 days. Nearly half of participants (47.2%) achieved a ≥50% reduction in MMD, compared to 27.0% on placebo. No new safety concerns were identified.
"Helping to prevent migraine attacks in children and adolescents is critical to supporting their healthy development and education, including missed school days, disability and overall social well-being," said Andrew D. Hershey, Endowed Chair and Director of Neurology at Cincinnati Children’s Hospital Medical Center and lead author of the study.
"The SPACE trial demonstrates that a CGRP-targeted preventive therapy like fremanezumab-vfrm (AJOVY) can significantly reduce the frequency of attacks of migraine in youth, giving physicians critical evidence to guide care for this underserved population."
With this milestone, Teva positions AJOVY as a groundbreaking option for young migraine sufferers, filling a long-standing gap in pediatric preventive care.
