Teva Pharmaceutical Industries Ltd. announced positive results from two Phase 2/3 trials evaluating AJOVY (fremanezumab) in patients in Japan. AJOVY is under development in Japan by Otsuka Pharmaceutical Co., Ltd. (Otsuka) as part of a May 2017 exclusive license agreement for development and sales of AJOVY in Japan.
“This study adds to the wealth of positive AJOVY data we have in patients globally,” said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache at Teva. “The annual prevalence of migraine in Japan is 8.4% of adults,1 so we are pleased to be one step closer to bringing AJOVY to patients in Japan who could benefit from a preventive treatment.”
Preliminary trial results indicated that primary endpoints were achieved with both clinical and statistical significance versus placebo for subjects with chronic migraine and episodic migraine, respectively. Statistically significant improvements versus placebo were also demonstrated for all secondary endpoints. AJOVY was well tolerated with a similar adverse events profile compared to placebo. Following additional analysis, more detailed results will be presented at upcoming medical congresses and publications. These are pivotal studies that will enable filing for Pharmaceuticals and Medical Devices Agency (PMDA) approval for marketing authorization.
AJOVY is the first and only anti-CGRP drug approved in the US and EU that is designed for the preventive treatment of migraine that offers both quarterly and monthly dosing options.