Bengaluru, May 27(PTI) Biocon Ltd. announced on Wednesday its subsidiary Biocon Biologics has received the Drugs Controller General of India’s approval for an extracorporeal blood purification device CytoSorb to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure.
The licence, which will be effective until control of the COVID-19 outbreak in the country, was granted in public interest to treat COVID-19 patients who are 18 years or older, the Bengaluru-headquartered Biocon said in a statement.
Studies have shown that COVID-19 patients who develop serious complications experience a cytokine storm, also known as Cytokine Release Syndrome which leads to excessive inflammation, organ failure and death, according to the company.
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, it said.
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.
Biocon’s Executive Chairperson Kiran Mazumdar-Shaw said CytoSorb is an in-licensed device that reduces cytokine storm in critically ill patients and was introduced by the company in India in 2013.
Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it, she 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.
CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus, Mazumdar-Shaw 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, and extracorporeal membrane oxygenation machines, Biocon said.
In April, the US Food and Drug Administration granted Emergency Use Authorisation of CytoSorb for use in patients with COVID-19 infection, the statement added.