31 July 2020 - - Japan-based Otsuka Pharmaceutical Co., Ltd. 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, Israeli pharmaceutical company Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) said.

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.

Ajovy is the first and only long-acting anti-CGRP subcutaneous injection approved in the US and EU that is designed for the preventive treatment of migraine and offers both quarterly and monthly dosing options.

Teva Pharmaceutical Industries is in generic and specialty medicines, with a portfolio consisting of over 3,500 products in nearly every therapeutic area.