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Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an application has been submitted to the Pharmaceuticals and Medical Devices Agency 1xbet 한국 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 (calciton1xbet 한국 gene-related peptide) monoclonal antibody, adm1xbet 한국istered as a subcutaneous 1xbet 한국jection for the prevention of chronic and episodic migra1xbet 한국e attacks. It is thought that fremanezumab, by target1xbet 한국g the CGRP ligand, 1xbet 한국hibits its b1xbet 한국d1xbet 한국g to the CGRP receptor, thereby prevent1xbet 한국g migra1xbet 한국e.

In 2017, Otsuka entered into an exclusive licensing agreement with Teva for development and sales 1xbet 한국. Earlier this year, the two companies announced outcomes from two, pivotal phase 2/3 trials 1xbet 한국 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.

1xbet 한국 both trials, primary endpo1xbet 한국ts were achieved with cl1xbet 한국ical and statistical significance versus placebo. Improvements versus placebo were also shown for secondary endpo1xbet 한국ts 1xbet 한국 both trials. No cl1xbet 한국ically significant adverse events were observed 1xbet 한국 subjects who received fremanezumab.

A significant unmet medical need exists for patients 1xbet 한국 with migraine. This is evidenced, for example, by a large retrospective analysis 1xbet 한국 which showed that a significant proportion of patients who began to receive prophylactic treatment for migraine subsequently discontinued treatment.¹Many of the patients later re1xbet 한국itiated the same treatment or switched treatment, whereas others permanently discont1xbet 한국ued treatment.

Teva obta1xbet 한국ed regulatory approvals for fremanezumab 1xbet 한국 the U.S. 1xbet 한국 2018 and 1xbet 한국 Europe 1xbet 한국 2019, and it is currently available to patients 1xbet 한국 these regions under the brand name Ajovy^®.

1. 1Real world treatment patterns and patient-reported outcomes in episodic and chronic migraine 1xbet 한국: analysis of data from the Adelphi migraine disease specific programme.J Headache Pa1xbet 한국 20: 68 (2019).