Teva touts first CGRP success in Phase III paediatric migraine prevention study

18 Jul 2024
firstwordpharma.com
Phase 3Clinical ResultDrug Approval
Teva is looking to expand its migraine prevention portfolio into the paediatric market, announcing positive results Thursday from the Phase III SPACE study evaluating Ajovy (fremanezumab) in children and adolescents. According to Teva, this is the first time an anti-CGRP monoclonal antibody has shown efficacy in this population.
Teva estimates that migraines affect about 7.7% of children, with prevalence rising from 5% in kids aged 5 to 10 to around 15% in teenagers. "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," said Chief Medical Officer Eric Hughes.
The trial randomised 235 subjects between the ages of 6 and 17 years to receive subcutaneously administered Ajovy or placebo over a 12-week period to prevent episodic migraines. Teva said the study met its primary endpoint, with Ajovy patients experiencing significantly fewer monthly migraine days compared to placebo.
"The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations," the company said.
So far, all other CGRP antibodies in the US — Amgen's Aimovig (erenumab), Lundbeck's Vyepti (eptinezumab) and Eli Lilly's Emgality (galcanezumab)  — are only approved for adults. Ajovy was greenlit in the US as a preventative migraine treatment for adults in 2018 and was later also cleared in Europe.
Amgen and Lundbeck are also testing their respective products in paediatric patients with chronic or episodic migraine. Aimovig is being evaluated in Amgen's OASIS(EM) and OASIS(CM) studies, both due to complete in 2027, while Vyepti is being investigated in the Phase III PROSPECT-1 and PROSPECT-2 trials, which are expected to wrap up towards the end of this year.
Teva noted that the efficacy seen in the SPACE study was "consistent" with pivotal Phase III and real-world evidence in adults. No new emergent safety signals emerged. Full data will be presented at a medical meeting later this year.
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