Teva Pharmaceutical Industries Ltd (NYSE:TEVA) announced on Thursday topline results from its Phase 3 SPACE study evaluating the efficacy of Ajovy (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17.
The trial met its primary endpoint with Ajovy achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo.
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Safety data was consistent with that observed in adult populations, with no emergent safety signals.
Full data from the SPACE study will be presented at a medical meeting later this year.
In September 2018, the FDA approved Ajovy as the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults.
"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," said Eric Hughes, executive vice president, Global R&D and chief medical officer, at Teva Pharmaceuticals.
The SPACE data are the first Phase 3 trial evidence of safety and efficacy of an anti-CGRP monoclonal antibody for migraine in a pediatric population.
The results have particular significance given the lack of preventive migraine treatments approved for use in children and adolescent populations.
Migraines are common among children, with an overall estimated prevalence of 7.7%.
The prevalence increases from 5% among children aged 5 to 10 years to approximately 15% among adolescents.
Last year, a federal judge in Massachusetts overturned a $176.5 million jury verdict against Eli Lilly And Co (NYSE:LLY). The verdict favored Teva Pharmaceutical and found that Lilly's migraine drug, Emgality, infringed upon three patents related to Teva's rival drug, Ajovy.
In April, AbbVie Inc (NYSE: ABBV) released an interim analysis of an ongoing Phase 3, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine.
TEVA Price Action: TEVA stock is up 0.49% at $16.46 at last check Thursday.
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