Biocon gets DCGI nod for CytoSorb use in critical Covid-19 cases

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BENGALURU: Biocon said its subsidiary Biocon Biologics has received the Drugs Controller General of India’s (DCGI) approval for an extracorporeal blood purification (EBP) device CytoSorb to reduce pro- inflammatory cytokines levels in confirmed ovid-19 patients admitted to ICU with confirmed or imminent respiratory failure.

Biocon Biologics has been granted licence for emergency use of CytoSorb by the drug regulator on patients who are 18 years of age or older. The licence will be effective until the outbreak is controlled, Biocon said on Wednesday.

This comes at a time when the US Food and Drug Administration (FDA) granted emergency usage of CytoSorb for use in coronavirus affected patients.

“CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013. DCGI approval for emergency use of CytoSorb for critical Covid-19 patients is an important example of how industry and regulators are working in tandem to urgently provide physicians and patients,” executive chairperson Kiran Mazumdar-Shaw said.

Studies have shown that Covid-19 patients who develop serious complications experience a ‘cytokine storm,’ also known as 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.