Teva Validates AJOVY® Efficacy and Safety in China Phase 3 Migraine Trial

15 April 2024 | Monday | News

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd.announced results from a Phase 3 study evaluating the efficacy and safety of AJOVY for the prevention of migraine in adult Chinese patients.
Image Source : Public Domain

Image Source : Public Domain

  • AJOVY confirms efficacy in new Phase 3 data significantly reducing the number of migraine days per month
  • All critical efficacy endpoints met significance as set out apriori through hierarchical testing
  • AJOVY confirmed a favorable safety profile

In the study, AJOVY achieved primary endpoint and all secondary endpoints, significantly reducing the number of migraine days experienced per month, demonstrating superior efficacy over placebo. All key secondary endpoints were also met including measures for early onset of efficacy during the first month, responder rate analysis defined as 50% reduction of migraine days and reduction of acute headache medication use over 3 months after first use. Study data also show AJOVY was safe and well tolerated with no emerging safety signals. This data is consistent with the previous Phase 3 data for AJOVY which was approved for the preventive treatment of migraine in adults in the U.S. in 2018 and in the EU in 2019.

In China, an estimated 14.3% of non-elderly adults are living with migraine.1 From this population, approximately 52.9% will visit hospitals and only 13.8% of them will be diagnosed with migraine.2

“Migraine and its debilitating symptoms impact people around the world, and these study results from Chinese migraine patients reinforce AJOVY as a proven preventive medicine that can safely and effectively help reduce the burden of migraine,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "China has the largest migraine population worldwide,3 and Teva is committed to research on a global scale that helps address unmet need where it exists and ensure that the role of treatment innovations like AJOVY are better understood.”

Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks. The burden of migraine and the fear of the next one can lead to a significant negative impact on quality of life, including family, social and professional relationships. People who experience migraine are more likely to suffer from anxiety and depression compared to healthy individuals.4

AJOVY is a humanized monoclonal antibody (mAb) which selectively binds the calcitonin gene-related peptide (CGRP).

In the Phase 3 double-blind study in China, 365 adult participants were randomized 1:1:2 to receive AJOVY subcutaneously 225mg once-monthly for three months or a single dose of 675mg once-quarterly or placebo.

"For the many millions of migraine patients in China,1 there is a need for preventive treatment options that may help reduce the number of migraine days they experience and support the alleviation of the incapacitating symptoms migraine can cause,” said Shengyuan Yu, MD, PhD, Director and Professor, Department of Neurology, Chinese PLA General Hospital. "These Phase 3 data indicate that fremanezumab has the potential to significantly improve life quality of the patients with migraine in China.”

In the study, AJOVY was safe and well tolerated with no safety signals observed. The most common treatment-related (≥5%) AEs were injection site reactions.


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