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Biocon gets approval for device to treat critical Covid-19 patients
The Bengaluru-based global biopharmaceuticals company said in a regulatory filling the license will be effective until Covid-19 is controlled in India.
Biocon Ltd said on Wednesday its subsidiary, Biocon Biologics, has got a nod from the Drugs Controller General of India (DCGI) for the use of an extracorporeal blood purification (EBP) device in treatment of the patients of the coronavirus disease (Covid-19).
The Bengaluru-based global biopharmaceuticals company said in a regulatory filling the license will be effective until Covid-19 is controlled in India.
It will be used for emergency use of CytoSorb to treat patients who are 18 or above and have been admitted to the intensive care units (ICU) with confirmed or imminent respiratory failure, it added.
“As a science-led organization, Biocon’s endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013,” Kiran Mazumdar-Shaw, the company’s executive chairperson, said.
“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,” she added.
“CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus.”
The company said 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,” the company added.
India on Wednesday reported more than 150,000 infections, including 80,004 active cases and 4,337 deaths.
