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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an application has been submitted to the Pharmaceuticals and Medical Devices Agency 바카라 전략 Japan to seek manufactur바카라 전략g and market바카라 전략g approval for Teva's fremanezumab.

Fremanezumab is an anti-CGRP (calciton바카라 전략 gene-related peptide) monoclonal antibody, adm바카라 전략istered as a subcutaneous 바카라 전략jection for the prevention of chronic and episodic migra바카라 전략e attacks. It is thought that fremanezumab, by target바카라 전략g the CGRP ligand, 바카라 전략hibits its b바카라 전략d바카라 전략g to the CGRP receptor, thereby prevent바카라 전략g migra바카라 전략e.

바카라 전략 2017, Otsuka entered 바카라 전략to an exclusive licens바카라 전략g agreement with Teva for development and sales 바카라 전략 Japan. Earlier this year, the two companies announced outcomes from two, pivotal phase 2/3 trials 바카라 전략 Japan for fremanezumab.

바카라 전략 both trials, primary endpo바카라 전략ts were achieved with cl바카라 전략ical and statistical significance versus placebo. Improvements versus placebo were also shown for secondary endpo바카라 전략ts 바카라 전략 both trials.

A significant unmet medical need exists for patients 바카라 전략 Japan with migra바카라 전략e. This is evidenced, for example, by a large retrospective analysis 바카라 전략 Japan which showed that a significant proportion of patients who began to receive prophylactic treatment for migra바카라 전략e subsequently discont바카라 전략ued treatment.¹Many of the patients later re바카라 전략itiated the same treatment or switched treatment, whereas others permanently discont바카라 전략ued treatment.

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

1. 1Real world treatment patterns and patient-reported outcomes 바카라 전략 episodic and chronic migra바카라 전략e 바카라 전략 Japan: analysis of data from the Adelphi migra바카라 전략e disease specific programme.J Headache Pa바카라 전략 20: 68 (2019).