New Delhi: Bengaluru-based Biocon Biologics has received the drug regulator’s nod for its blood purification device CytoSorb to treat critical Covid-19 patients.
CytoSorb has been allowed for reducing cytokines levels in Covid-19 patients admitted to intensive care units with confirmed or imminent respiratory failure, the company said in a statement Wednesday.
“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,” it said.
CytoSorb was introduced in India in 2013 with an initial focus on treating sepsis, one of the largest indications for the use of the product.
The Drugs Controller General of India’s licence for CytoSorb will be effective until the Covid-19 outbreak in the country comes under control, the statement said.
In April, the US Food and Drug Administration had granted Emergency Use Authorization of CytoSorb for use in patients with Covid-19 infection.
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CytoSorb use
While antibiotics are used to control any primary infection, concurrent use of CytoSorb helps control the excessive inflammatory response, remove certain bacterial toxins, and avoid cell-mediated injury to otherwise healthy organs, according to Biocon’s website.
“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, Biocon, told ThePrint.
“CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus,” she added.
High levels of cytokines, also known as ‘cytokines storm’, cause multiple organ failure leading to death. According to the US National Cancer Institute, cytokines storm is a severe immune reaction in which the body releases too many cytokines into the blood too quickly.
Early research suggests many of the fatal cases of Covid 19 result from over-activation of a person’s immune system.
Promoted as simple to use, CytoSorb is a ‘plug-and-play’ device compatible with the most commonly used blood purification machines or pumps in the ICU used to treat Covid-19 patients, such as hemodialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines.
CytoSorb therapy has been used in the past in over 56,000 human treatments in more than 800 clinical departments around the world, the website adds.
Kiran Mazumdar-Shaw is among the distinguished founder-investors of ThePrint. Please click here for details on investors.
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How are they pricing cytosorb for this use? I hear that it costs 96000 rupees per filter cartridge.