The device is going to be used for extracorporeal blood purification (EBP) to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients who have been admitted to the intensive care unit with confirmed or imminent respiratory failure, said the company in a press release.
The United States Food and Drug Administration in April approved CytoSorb for emergency use in Covid-19 patients.
Biocon Biologics has been granted licence for emergency use of CytoSorb in public interest by the Indian health regulator to treat coronavirus patients who are 18 years of age or older. The licence will be effective until control of the Covid-19 outbreak in the country, said the company.
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. CytoSorb therapy is aimed to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.
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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 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,” said Kiran Mazumdar-Shaw, executive chairperson, Biocon.