Coronavirus: Biocon Biologics gets DCGI approval for emergency use of CytoSorb to treat critical COVID-19 patients

Biocon Ltd, a Bengaluru-based global biopharmaceuticals company, on Wednesday announced that 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 COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

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Biocon Biologics has been granted licence for emergency use of CytoSorb in the public interest by the Indian health regulator to treat COVID-19 patients who are 18 years of age or older, the company said in a statement.

The licence will be effective until control of the COVID-19 outbreak in the country. 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.

The company has received approval from DCGI in Form MD-15 (Medical Device) for reducing pro-inflammatory cytokine levels in order to control the ‘cytokine storm’ and benefit COVID-19 patients who are in a critical condition.

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 device that reduces cytokine storms 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. 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 with new treatment options in the fight against COVID-19. CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus."

With more than one lakh documented active coronavirus infections and over 4,000 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, including hemoperfusion, hemodialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines.

In April, the US Food and Drug Administration (FDA) granted Emergency Use Authorisation (EUA) of CytoSorb for use in patients with COVID-19 infection, the company said.