Drug Controller General of India has given the nod for restricted emergency use of Itolizumab in the treatment of COVID-19 patients.
Itolizumab (rDNA origin), a monoclonal antibody drug, has been manufactured and marketed by Biocon Limited since 2013. It has been used to treat severe chronic plaque psoriasis. The psoriasis drug was used in clinical trials of COVID-19 patients by Biocon. The results showed that there was an improvement in PaO2 and O2 saturation in lung function and prevention of hyper-inflammation in COVID-19 patients. Biocon presented the clinical study and its results to the DCGI which granted permission for restricted emergency use for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients of COVID-19.
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