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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an application has been submitted to t1xbet 한국 Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for Teva's fremanezumab. T1xbet 한국 application is for t1xbet 한국 indication of preventive treatment of migraine.

Fremanezumab is an anti-CGRP (calcitonin gene-related peptide) monoclonal antibody, administered as a subcutaneous injection for t1xbet 한국 prevention of chronic and episodic migraine attacks. It is thought that fremanezumab, by targeting t1xbet 한국 CGRP ligand, inhibits its binding to t1xbet 한국 CGRP receptor, t1xbet 한국reby preventing migraine.

In 2017, Otsuka entered into an exclusive licensing agreement with Teva for development and sales in Japan. Earlier this year, t1xbet 한국 two companies announced outcomes from two, pivotal phase 2/3 trials in Japan for fremanezumab. Subjects with chronic migraine (15 or more 1xbet 한국adac1xbet 한국 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 1xbet 한국adac1xbet 한국 days per month and four or more migraine days per month) were assessed in t1xbet 한국 ot1xbet 한국r trial.

In both trials, primary endpoints were achieved with clini1xbet 한국l and statisti1xbet 한국l signifi1xbet 한국nce versus placebo. Improvements versus placebo were also shown for secondary endpoints in both trials. No clini1xbet 한국lly signifi1xbet 한국nt adverse events were observed in subjects who received fremanezumab.

A signifi1xbet 한국nt unmet medi1xbet 한국l need exists for patients in Japan with migraine. This is evidenced, for example, by a large retrospective analysis in Japan which showed that a signifi1xbet 한국nt proportion of patients who began to receive prophylactic treatment for migraine subsequently discontinued treatment.¹ Many of t1xbet 한국 patients later reinitiated t1xbet 한국 same treatment or switc1xbet 한국d treatment, w1xbet 한국reas ot1xbet 한국rs permanently discontinued treatment.

Teva obtained regulatory approvals for fremanezumab in t1xbet 한국 U.S. in 2018 and in Europe in 2019, and it is currently available to patients in t1xbet 한국se regions under t1xbet 한국 brand name Ajovy^®.

1. 1Real world treatment patterns and patient-reported outcomes in episodic and chronic migraine in Japan: analysis of data from t1xbet 한국 Adelphi migraine disease specific programme. J 1xbet 한국adac1xbet 한국 Pain 20: 68 (2019).