The US Food and Drug Administration (FDA) issued an emergency use authorisation for a blood purification system (Spectra Optia Apheresis System, Terumo BCT) combined with Adsorption Cartridge (Marker Therapeutics) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
A FDA statement reports that the devices work together to reduce the amount 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 statement adds that 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.
FDA commissioner Stephen M Hahn comments: “We continue to work across all sectors to expedite the development of numerous innovative potential preventive and treatment approaches by both facilitating emergency access for patients, to the extent we can, and supporting the evaluation of potential therapies. With today’s authorisation of a blood purification device, we are expediting the availability of a treatment option for patients in the ICU to help reduce the severity of the disease. Our staff will continue our around the clock review of all medical products to expedite the availability of treatments to help fight this devastating disease.”
Antoinette Gawin, CEO and president of Terumo BCT, and David Cohen, Chairman of Marker Therapeutics, says: “We thank the FDA for their expedited review, which provides another treatment option for patients in the ICU to help reduce the severity of the disease.”