Biocon gets DCGI nod for its itolizumab use in COVID-19 patients

India’s largest biotech firm Biocon (BSE: 5325230) has received the Drugs Controller General of India’s (DCGI) approval to market Alzumab (itolizumab) injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19, with the news nudging the company’s shares up more than 1% to 419.50 rupees this morning.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as Alzumab for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19.

Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.