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Biocon Biologics Receives DCGI Approval for Emergency Use of CytoSorb Blood Purifier

CytoSorb reduces pro-inflammatory cytokines levels in confirmed COVID-19 patients

Bengaluru: Biocon Ltd, a global biopharmaceuticals company, announced today 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.

Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said,“As a science-led organization, Biocon’s endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm 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,” she said.

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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.

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 U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of CytoSorb for use in patients with COVID-19 infection.

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