The US Food and Drug Administration (FDA) on Saturday authorised emergency use of a blood purification device to treat COVID-19 patients who are above 18 years of age. The treatment has been only authorised for patients admitted in the Intensive-Care Unit (ICU) with confirmed or imminent respiratory failure.
As per a FDA release, the product works 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.
A "cytokine storm" occurs in some COVID-19 patients, leading to severe inflammation, rapidly progressive shock, respiratory failure, organ failure, and death.
FDA Commissioner Stephen M. Hahn, M.D said, "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."
He added, "With today's authorization 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.