Biocon gets drug regulator's nod for CytoSorb device to treat critical COVID-19 patients

"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 added.

Biocon on May 27 said its subsidiary Biocon Biologics has received the Drugs Controller General of India (DCGI) approval for 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.

Biocon Biologics has been granted the 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 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 company said.

"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 added.

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.

“CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013," said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon.

"Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it," Mazumdar-Shaw said.

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, she said.

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, USFDA granted Emergency Use Authorization (EUA) of CytoSorb for use in patients with COVID-19 infection.

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