Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for Teva's fremanezumab. The application is for the indication of preventive treatment of migraine.

Fremanezumab is an anti-CGRP (calcitonin gene-related peptide) monoclonal antibody, administered as a subcutaneous injection for the prevention of chronic and episodic migraine attacks. It is thought that fremanezumab, by targeting the CGRP ligand, inhibits its binding to the CGRP receptor, thereby preventing migraine.

In 2017, Otsuka entered into an exclusive licensing agreement with Teva for development and sales in Japan. Earlier this year, the two companies announced outcomes from two, pivotal phase 2/3 trials in Japan for fremanezumab. Subjects with chronic migraine (15 or more headache days per month and eight or more migraine days per month) were assessed in one trial and subjects with episodic migraine (between six and 14 headache days per month and four or more migraine days per month) were assessed in the other trial.

In both trials, primary endpoints were achieved with clinical and statistical significance versus placebo. Improvements versus placebo were also shown for secondary endpoints in both trials. No clinically significant adverse events were observed in subjects who received fremanezumab.

A significant unmet medical need exists for patients in Japan with migraine. This is evidenced, for example, by a large retrospective analysis in Japan which showed that a significant proportion of patients who began to receive prophylactic treatment for migraine subsequently discontinued treatment.¹ Many of the patients later reinitiated the same treatment or switched treatment, whereas others permanently discontinued treatment.

Teva obtained regulatory approvals for fremanezumab in the U.S. in 2018 and in Europe in 2019, and it is currently available to patients in these regions under the brand name Ajovy^®.

1. 1Real world treatment patterns and patient-reported outcomes in episodic and chronic migraine in Japan: analysis of data from the Adelphi migraine disease specific programme. J Headache Pain 20: 68 (2019).