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The approval is for emergency use only in the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19
Biopharmaceuticals firm Biocon has received Drugs Controller General of India (DCGI) approval for use of its repurposed psoriasis drug Itolizumab injection 25mg/5mL solution in the treatment of COVID-19 patients.
The approval is for emergency use only in the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19, Biocon said.
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Announcing the DCGI approval, the company said Itolizumab will be manufactured and formulated as an intravenous injection at the bio-manufacturing facility in Biocon Park, Bengaluru.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. A monoclonal antibody launched in the country in 2013 as ALZUMAb for treating chronic plaque psoriasis, Itolizumab has been repurposed for the treatment of CRS in moderate to severe ARDS patients due to COVID-19, a statement from the company said.
The DCGI approval of Itolizumab is based on the results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved, Biocon said.
“The data is compelling and I am confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country. We plan to take this therapy to other parts of the world impacted by the pandemic,” said Executive Chairperson Kiran Mazumdar-Shaw.
