On Monday, shares of Biocon Ltd surged as much as 9.8 percent to Rs 446.95, its new 52-week high after the drugmaker announced that it has received an emergency use authorisation (EUA) for its monoclonal antibody Itoliuzumab from the Drug Controller General of India (DCGI) to treat cytokine storms, one of the leading causes of death among patients severely affected by COVID-19.
On Saturday, in a stock exchange filing, Biocon said it has received the DCGI's approval to market Itolizumab (ALZUMAbTM) 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.
"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 ALZUMAbTM for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19," it said.
"Itolizumab will be manufactured and formulated as an intravenous injection at Biocon's bio-manufacturing facility at Biocon Park, Bengaluru," it added.
The approval of Itolizumab, from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.
For the March-ended quarter, Biocon reported a 42.3 percent year-on-year decline in its consolidated net profit to Rs 123.40 crore while net sales rose 3.4 percent to Rs 1,581 crore during the period.