New York: The US Food and Drug Administration (FDA) has issued an emergency use authorisation for a blood purification system to treat certain coronavirus patients with serious conditions.
The authorisation is meant only for patients 18 years of age or older with confirmed coronavirus disease 2019 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure, the FDA said.
The authorised product works by reducing 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 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.
“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,” FDA Commissioner Stephen M. Hahn, said in a statement.
“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.” The FDA issued this emergency use authorisation to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
Terumo BCT, a global major in blood component, therapeutic apheresis and cellular technologies has its headquarters in Lakewood, Colorado, US. Marker Therapeutics is also a US-based company. It is a clinical-stage immuno-oncology company specialising in the development and commercialisation of novel T cell-based immunotherapies.