The company has received the DCGI approval to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) patients due to COVID-19, Biocon said in a BSE filing.
Biotechnology major Biocon on Saturday said it has received approval from the Drugs Controller General of India (DCGI) for use of its biologic drug Itolizumab for the treatment of moderate to severe COVID-19 patients. The company has received the DCGI approval to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) patients due to COVID-19, Biocon said in a BSE filing.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, it added. The company, however, did not disclose the price at which it will be selling the drug.
The firm has repurposed the drug, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as Alzumab for treating chronic plaque psoriasis, Biocon said. The drug will be manufactured and formulated as an intravenous injection at the company’s bio-manufacturing facility at Biocon Park, Bengaluru.
DCGI’s approval for Itolizumab is based on the results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi, Biocon said. “As an innovation-led biopharmaceuticals company, I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with COVID-19,” Biocon Executive Chairperson Kiran Mazumdar-Shaw said.
This positions India among the leading global innovators in their effort to overcome the COVID-19 pandemic, she added.
“We plan to take this therapy to other parts of the world impacted by the pandemic,”Mazumdar-Shaw said.
India’s coronavirus caseload zoomed past the eight-lakh mark on Saturday with a record single day increase of 27,114 cases.The death toll climbed to 22,123 with 519 people succumbing to the disease in 24 hours, according to health ministry data.