FDA grants emergency use authorisation to blood purification system for COVID-19

The US Food and Drug Administration (FDA) has issued an emergency use authorisation for a blood purification system to treat patients 18 years of age or older with confirmed cases of COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The product works by reducing the amount of cytokines and other inflammatory mediators, ie, 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 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," said FDA Commissioner Dr Stephen Hahn. "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."

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.
 

Register as Visitor to CPhI China 2020!

-----------------------------------------------------------------------
Editor's Note:

En-CPhI.CN is a vertical B2B online trade platform serving the pharmaceutical industry,

for any copyright disputes involved in the articles,

please email: Julia.Zhang@imsinoexpo.com to motify or remove the content.