Teva announces AJOVY study met all critical efficacy endpoints in China trial

Teva Pharmaceuticals announced results from a Phase 3 study evaluating the efficacy and safety of AJOVY for the prevention of migraine in adult Chinese patients. 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. “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…In the study, AJOVY was safe and well tolerated with no safety signals observed. The most common treatment-related AEs were injection site reactions. Additional findings from this study are planned for presentation at a medical meeting later this year.