DCGI permits use of Biocon Biologics’ CytoSorb to treat COVID-19 patients

Biocon’s subsidiary Biocon Biologics has received Drugs Controller General of India’s (DCGI) approval to use CytoSorb to treat critical COVID-19 patients. This is an extracorporeal blood purification (EBP) device which can help reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The Indian health regulator has granted licence to the company for emergency use of this device to treat COVID-19 patients who are 18 years of age or older. The licence will be valid until control of the COVID-19 outbreak in the country.

In April, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of CytoSorb to treat COVID-19 patients. Now, it received approvals from the India regulator.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said, “As a science-led organisation, Biocon’s endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm in critically-ill patients and was introduced by Biocon in India in 2013.”

Cytokines storm also known as Cytokine Release Syndrome (CRS), leads to excessive inflammation, organ failure and death. According to various studies, COVID-19 patients have faced this complication.

This device therapy will reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.