Regarding an approval for the interim order of “TORAYMYXIN” to treat COVID-19 patients in Canada

Published : Wednesday, April 22, 2020, 2:21 pm
ACROFAN=Seunghee Shin | | SNS
Toray Industries, Inc. and Toray Medical Co., Ltd. announced that Canadian Authority, Health Canada has issued an Interim Order for use of an endotoxin adsorption cartridge, TORAYMYXIN® to treat patients with the novel coronavirus (“COVID-19”).

COVID-19, the novel coronavirus (SARS-CoV-2) is an infectious disease that causes organ dysfunction including respiratory failure with worsening disease conditions. As the COVID-19 pandemic accelerates,“Interim order respecting the Importation and sale of medical devices for use in relation to COVID-19” has been established by Health Canada.

Toray has possessed the Canadian Import License for TORAYMYXIN® to treat patients with septic shock since its approval in 2003 (License Number: 63404). In addition to the current indications, Toray applied for the authorization of the interim order for TORAYMYXIN® to treat COVID-19 patients, and was granted expanded indications for use on April 17 as follows.

Expanded indications for the interim order

When TORAYMYXIN is used for COVID-19 patients, indications are as follows:
Acute respiratory failure in the absence of cardiac failure or fluid overload
Having diffuse alveolar damage (DAD) (HRCT findings)
PaO2/FiO2 =< 300 mmHg

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