Teva's first CGRP success in Phase III pediatric migraine study

Teva Pharmaceuticals is aiming to broaden its migraine prevention offerings for the pediatric market, having announced promising results from the Phase III SPACE study, which tested Ajovy (fremanezumab) in children and adolescents. According to Teva, this marks the first instance of an anti-CGRP monoclonal antibody demonstrating efficacy in a younger population.

Teva estimates that migraines impact approximately 7.7% of children, with the prevalence increasing from 5% in those aged 5 to 10 to about 15% in teenagers. Chief Medical Officer Eric Hughes remarked that the SPACE study data supports Teva's goals of extending Ajovy's benefits to younger patients who have limited treatment options available.

In the trial, 235 participants aged 6 to 17 were randomly assigned to receive either subcutaneously administered Ajovy or a placebo over a 12-week period to prevent episodic migraines. The study achieved its primary endpoint, with Ajovy recipients experiencing significantly fewer monthly migraine days compared to the placebo group.

Teva highlighted the importance of these results given the scarcity of approved preventive migraine treatments for children and adolescents. Currently, all other CGRP antibodies available in the US, such as Amgen's Aimovig (erenumab), Lundbeck's Vyepti (eptinezumab), and Eli Lilly's Emgality (galcanezumab), are approved solely for adult use. Ajovy was approved in the US as a preventive migraine treatment for adults in 2018 and subsequently in Europe.

Amgen and Lundbeck are also exploring their respective products for pediatric use in patients with chronic or episodic migraines. Aimovig is being tested in Amgen's OASIS(EM) and OASIS(CM) studies, both expected to conclude in 2027. Meanwhile, Vyepti is under investigation in the Phase III PROSPECT-1 and PROSPECT-2 trials, which are anticipated to complete by the end of this year.

Teva also noted that the efficacy observed in the SPACE study aligns with previous Phase III and real-world evidence in adults. Moreover, no new safety concerns emerged during the study. Detailed findings will be shared at a medical conference later this year.