Apr. 22, 2020
Toray Industries, Inc.
Regarding an approval for the interim order of“TORAYMYXIN®” to treat COVID-19 patients in Canada
Tokyo, Japan, April 22, 2020 – Toray Industries, Inc. and Toray Medical Co., Ltd. are pleased to announce 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
Meanwhile, our license partner has gained an approval for a supplemental Investigational Device Exemption (IDE) from the U.S. Authority, Food and Drug Agency (FDA) for TORAYMYXIN® to treat COVID-19 patients in a clinical study in the U.S.
Since its first distribution in Japan in 1994, this device has been mainly used to treat patients with severe sepsis and septic shock caused by endotoxemia or suspected gram-negative infection.
Toray is a leading global company in innovative technologies and advanced materials. Since its foundation in 1926, the Company has contributed to society through the creation of new value and addressed global challenges by delivering high value-added products including fibers and textiles, resins and films, and carbon fiber composite materials. It operates in 26 countries and regions with about 48,000 employees worldwide.
For more information, please visit our website at www.toray.com.