29 July 2020 - Teva Pharmaceutical Industries today announced Otsuka has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for Ajovy (fremanezumab) injection for the preventive treatment of migraine.

Ajovy is under development in Japan by Otsuka as part of a May 2017 exclusive license agreement for development and sales of Ajovy in Japan. 

Earlier this year, the two companies announced outcomes from two pivotal studies of Ajovy in Japan in patients with episodic and chronic migraine. The primary endpoints were achieved in both trials with clinical and statistical significance versus placebo. Statistically significant improvements versus placebo also were demonstrated for all secondary endpoints. Ajovy was well tolerated with a similar adverse events profile compared to placebo.

Read Teva Pharmaceuticals press release