Biocon gets DCGI nod for device to treat critical COVID-19 patients

US FDA recently approved CytoSorb for emergency use in COVID-19 patients

Biotechnology major Biocon on Wednesday said its subsidiary has received approval from the Drugs Controller General of India (DCGI) for a medical device CytoSorb to reduce pro-inflammatory cytokines (indicator of pain) levels in confirmed COVID-19 patients.

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A statement from Biocon said, Biocon Biologics has been granted licence for emergency use of CytoSorb in public interest by the Indian health regulator to treat CoVID-19 patients over 18 years of age. The licence will be effective until the control of the CoVID-19 outbreak in the country.

Studies have shown that CoVID-19 patients who develop serious complications experience a ‘cytokine storm’ (an overprotective immune response), also called Cytokine Release Syndrome (CRS), which leads to excessive inflammation, organ failure and death. “The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented,” said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon.

Ms. Mazumdar-Shaw, added: “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. Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it.”

With more over than 1.5 lakh documented active coronavirus infections and over 4,300 deaths, India needs new therapies to reduce the severity of this disease. CytoSorb is plug-and-play compatible with the most commonly used blood purification machines or pumps in the ICU used to treat COVID-19 patients.