Teva: Clinical Trials With Migraine Drug AJOVY Report Positive Results In Japan

(RTTNews) - Israeli generic medicines producer Teva Pharmaceutical Industries Ltd. (TEVA) announced Monday 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. as part of a May 2017 exclusive license agreement for development and sales of AJOVY in Japan.

The company noted that 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.

The company noted that these are pivotal studies that will enable filing for Pharmaceuticals and Medical Devices Agency or 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.