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 31, 2020 20:49:39 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

Coronavirus Outbreak: Member of Maharashtra govt's COVID-19 task force tests positive
India

Coronavirus Outbreak: Member of Maharashtra govt's COVID-19 task force tests positive

The task force of nine senior doctors was formed on 13 April in view of increasing number of coronavirus cases and deaths in the state, especially in Mumbai.

'US will have 100,000 new coronavirus cases a day,' warns top health expert Anthony Fauci as country sees around 40,000 new infections a day
World

'US will have 100,000 new coronavirus cases a day,' warns top health expert Anthony Fauci as country sees around 40,000 new infections a day

Fauci said the daily increase in new coronavirus cases in the United States, currently around 40,000, could reach 100,000 unless a full nationwide effort was undertaken to tamp down the resurgent virus.

Coronavirus Updates: Confirmed cases in Maharashtra cross two lakh with 7,074 new infections reported today; toll reaches 8,671
India

Coronavirus Updates: Confirmed cases in Maharashtra cross two lakh with 7,074 new infections reported today; toll reaches 8,671

Coronavirus Updates: According to a state health department bulletin, over 1.98 lakh patients have been discharged till date and the recovery rate stands at 54.02 percent