LAKEWOOD, CO. USA – 10 April 2020 – Terumo BCT, Inc. and Marker Therapeutics AG announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the use of Terumo BCT’s Spectra Optia® Apheresis System combined with Marker Therapeutics’ D2000 Adsorption Cartridge to treat patients 18 years of age or older with confirmed Coronavirus Disease 2019 (COVID-19) admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels.
The devices work together by reducing the number of cytokines and other inflammatory mediators, i.e., small active proteins in the bloodstream that control a cell’s immune response by filtering the blood and returning the filtered blood to the patient. The proteins that are removed are typically elevated during infections and can be associated with a “cytokine storm” that occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure and death.
“We thank the Food and Drug Administration for their expedited review, which provides another treatment option for patients in the ICU to help reduce the severity of the disease,” say Antoinette Gawin, CEO and President of Terumo BCT, and David Cohen, Chairman of Marker.
About Terumo BCT and Marker
Therapeutics Collaboration
Terumo BCT, a U.S. based leader in blood component, therapeutic
apheresis and cellular technologies, and Marker Therapeutics AG, a Swiss-based
diagnostic and therapeutics company, formed this collaboration to combine their
existing technologies to provide an innovative approach to potentially treat
severe respiratory symptoms caused by COVID-19.
“The pace of this collaboration between the companies is incredible. We are leaving no stone unturned in exploring existing and new ways for our products to mitigate the impact of COVID-19,” says Antoinette Gawin, CEO and President of Terumo BCT.
“By combining our plasma adsorption cartridge with Terumo BCT’s technology, this partnership offers the potential to develop a unique global solution for treatment of acute respiratory failure in COVID-19,” says David Cohen, Chairman of Marker.
About Emergency Use Authorization
Status
The Spectra Optia Apheresis System with the D2000 Adsorption Cartridge
has been neither cleared nor approved for the indication to treat patients with
COVID-19 infection; it has been authorized by the FDA under EUA 200148 for emergency use to treat patients 18
years of age or older with confirmed COVID-19 admitted to the ICU with
confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine
levels, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act
(the Act) (21 U.S.C. §360bbb-3).
There are no FDA-approved, licensed, or cleared device treatments for COVID-19.
Terumo BCT’s Spectra Optia® Apheresis System combined with Marker Therapeutics AG’s D2000 Adsorption Cartridge has the potential to reduce the levels of inflammatory cytokines responsible for acute respiratory failure in COVID-19 patients.
The Spectra Optia Apheresis System with the D2000 Adsorption Cartridge is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Spectra Optia Apheresis System with the D2000 Adsorption Cartridge under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
