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  5. Otsuka announces positive top-line results from clinical trials in Japan offremanezumab as a prophylactic treatment for migraine

January 27, 2020

Otsuka Pharmaceutical Co., Ltd.


Otsuka announces positive top-line results from clinical trials in Japan of
fremanezumab as a prophylactic treatment for migraine

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that positive preliminary results were obtained in two, phase 2/3 trials for fremanezumab as a prophylactic migraine drug.

Fremanezumab is an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody. It is administered as a subcutaneous injection for the prevention of chronic and episodic migraine. Fremanezumab is under development in Japan by Otsuka, which entered into an exclusive license agreement with Teva Pharmaceutical Industries, Ltd. (Teva) in May 2017 for development and sales in Japan. Fremanezumab is a humanized monoclonal antibody (mAb) that prevents migraine by binding to the CGRP ligand and blocks its binding to the receptor.

Two, phase 2/3 trials were conducted as multi-center, randomized, double-blind, placebo-controlled trials. One trial assessed subjects with chronic migraine (15 or more headache days and eight or more migraine days per month) and the other trial assessed subjects with episodic migraine (between six and 14 headache days per month and four or more migraine days per month).

Preliminary trial results indicated that primary endpoints were achieved with statistical significance versus placebo for subjects with chronic migraine and episodic migraine, respectively. Improvements versus placebo were also shown for secondary endpoints. No clinically significant adverse events were observed in subjects who received fremanezumab. Following additional analysis, more detailed results will be announced at a medical congress.

Information in this news release was current as of the original release date.

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