Biocon gets DCGI nod for CytoSorb device to treat Covid-19 patients

CytoSorb therapy reduces cytokine storm and the inflammatory response in Covid-19 patients through blood purification so that injury to organs may be mitigated or prevented

Biocon’s subsidiary Biocon Biologics has received approval from the Drugs Controller General of India (DCGI) to use CytoSorb for treatment of Covid-19 patients. It is a device that reduces pro-inflammatory cytokine levels in Covid-19 patients admitted to the intensive care unit, with confirmed or imminent respiratory failure.

A cytokine is a substance, such as interferon or interleukin, that is secreted by certain cells of the immune system and has an effect on other cells.

Biocon Biologics has been granted licence for emergency use of CytoSorb to treat Covid-19 patients aged 18 years or more. The licence will be effective until control of the Covid-19 outbreak in the country.

“CytoSorb will be an important addition to the Indian medical community’s arsenal against Covid-19 patients. 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 the virus,” said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon. The device was introduced in India by Biocon in 2013.

The company has a small inventory of the device in India. “If the usage goes up, we can easily import more devices from the US,” said Shaw.

To date, more than 750 critically ill patients with Covid-19 infection have been treated with CytoSorb in various centers in Italy, China and Germany.

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 inflammatory response through blood purification so that this injury may be mitigated or prevented.

Medical experts say there’s no conclusive data to prove that CytoSorb is beneficial for Covid-19 patients. “There is no conclusive evidence to prove that CytoSorb therapy will be beneficial for Covid-19 patients. It has been earlier used to treat sepsis but trials lasted years,” said Vimal Bharadwaj, a medical practitioner at the department of critical care medicine at Narayana Health in Bengaluru.

However, it is being touted as one of the adjunctive therapies which could be used to treat critical Covid-19 patients. “Each filter costs about Rs 90,000 and basically two sessions are required while the process is carried out over two to four days,” said Satyanarayana Mysore, HOD at Interventional Pulmonology & Sleep Medicine at Manipal Hospitals in Bengaluru.

In April, the US Food and Drug Administration granted Emergency Use Authorization of CytoSorb for use in patients with Covid-19 infection.