FDA Grants Emergency Use Authorization for CytoSorb in COVID-19 Patients

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to CytoSorbents Corporation for its blood purification technology Cytosorb for treatment of cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients for use in patients with coronavirus disease 2019 (COVID-19) infection, according to a statement from the CytoSorbents Corporation.

With the EUA, CytoSorb can now be made available through commercial sales to all US hospitals for use in patients 18 years of age and older with confirmed COVID-19 admitted to the ICU confirmed or imminent respiratory failure who have a multitude of other conditions including early acute lung injury (ALI), acute respiratory distress syndrome (ARDS), and severe and/or life-threatening disease.

"As a US based company with CytoSorb device manufacturing in New Jersey, we are eager to expand the availability of CytoSorb to U.S. hospitals and patients as a treatment option to fight cytokine storm and deadly inflammation that is believed to exacerbate COVID-19 infection,” said Phillip Chan, MD, PhD, Chief Executive Officer of CytoSorbents, in the aforementioned statement. “With more than 555,000 documented coronavirus infections, the US leads the world with over 22,000 deaths, and emergently needs new therapies to reduce the severity of this disease.”

With a multitude of studies and research indicating patients with COVID-19 experience a cytokine storm that is associated with increased injury to heart, lungs, and kidneys, the EUA could aid in reducing cytokine storm and deadly inflammation through blood purification. According to CytoSorbents, CytoSorb is a plug-and-play compatible with most blood purification machines or pumps in ICUs being used to treat COVID-19 patients, including hemoperfusion, hemodialysis, continues renal replacement therapy and ECMO machines.

A letter from the FDA noted bench performance testing and reported clinical experience suggests CytoSorb may be effective at treating certain patients with COVID-19 through removal not various pro-inflammatory cytokines for their blood. In addition to the aforementioned conditions, the eight-page letter, which was signed by RADM Denise Hinton, Chief Scientist for the FDA, notes multiple patients populations for use under the terms severe and life-threatening disease.

Severe disease was defined as dyspnea, respiratory frequency greater than 30 per minute, blood oxygen saturation less than 93%, partial pressure of arterial oxygen to fraction of inspired oxygen ratio less than 300 and/or lung infiltrations greater than 50% within 24 to 48 hours. Life-threatening disease was defined as respiratory failure, septic shock, and/or multiple organ dysfunction.

CytoSorbents Corporation stated the EUA will be effective until the declaration, that circumstances exist justifying the authorization of the emergency use of the CytoSorb device during the COVID-19 pandemic, is terminated under section 564(B)(2) of the Act, or the EUA is revoked under section 564(g) of the Act.