Biopharmaceuticals company Biocon on Wednesday announced that its subsidiary Biocon Biologics has received approval from the Drugs Controller General of India’s (DCGI) approval for a medical device used in treating Covid-19 patients.
In a regulatory filing, the Bengaluru-based company said, “Biocon Biologics has been granted licence for emergency use of CytoSorb in 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.”
CytoSorb, an extracorporeal blood purification (EBP) device, is used to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.
The company also said that 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,” it added.
“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,” Kiran Mazumdar-Shaw, Executive Chairperson of Biocon was quoted in the statement.
The Company has received approval from the 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 will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus,” Shaw added.
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.