Biocon gets DCGI nod for emergency use of CytoSorb to treat critical COVID-19 patients

Biotechnology major Biocon on Wednesday said its subsidiary has received approval from the Drugs Controller General of India (DCGI) for a medical device to treat critical COVID-19 patients

FP Staff May 27, 2020 12:38:12 IST
Biocon gets DCGI nod for emergency use of CytoSorb to treat critical COVID-19 patients

Biotechnology major Biocon on Wednesday announced that its subsidiary BioconBiologics has received the Drugs Controller General of India’s(DCGI) approval for an extracorporeal blood purification (EBP) deviceCytoSorb to reduce pro-inflammatory cytokines levels in confirmed COVID-19patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure.

The company has been granted a licence for emergency use of CytoSorb in public interest to treat COVID-19 patients who are 18 years of age or older, it added.

The license will be effective until control of the COVID-19 outbreak in the country, Biocon said in statement.

"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," Biocon Executive Chairperson Kiran Mazumdar-Shaw said.

CytoSorb will be an important addition to the Indian medical community's arsenal against the deadly coronavirus, she added.

Click here to follow LIVE updates on coronavirus outbreak

The device 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.

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.

Click here to follow LIVE news and updates on stock markets

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.

Biocon Biologics 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, the company said.

In April, the US Food and Drug Administration had granted emergency use authorisation of CytoSorb for use in patients with COVID-19.

Updated Date:

also read

COVID-19 update: India reports 2,841 new cases, nine deaths in last 24 hours, active cases dip to 18,604
India

COVID-19 update: India reports 2,841 new cases, nine deaths in last 24 hours, active cases dip to 18,604

The fresh COVID-19 infections reported on Friday were marginally higher than 2,827 cases logged on Thursday. The daily positivity rate was recorded at 0.58 per cent, while the weekly positivity rate was 0.69 per cent

India logs 2,202 new COVID-19 cases in last 24 hours, down 11.45% from day ago; daily positivity rate up at 0.74%
India

India logs 2,202 new COVID-19 cases in last 24 hours, down 11.45% from day ago; daily positivity rate up at 0.74%

India now has 17,317 active cases of COVID-19, a decline of 375 cases in the active caseload in a span of 24 hours. The active cases now comprise of 0.04 per cent of the total infections

SII seeks permission for next trial of Covovax as booster dose in children aged 2 to 18 years
India

SII seeks permission for next trial of Covovax as booster dose in children aged 2 to 18 years

The Drugs Controller General of India (DCGI) had granted permission in March for conducting Phase-3 clinical trial of Covovax as a booster dose in adults