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Biocon gets DCGI’s nod to market Itolizumab Injection

13 Jul 2020 Evaluate

Biocon has received the Drugs Controller General of India's (DCGI) approval to market Itolizumab (ALZUMAb) 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 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.

Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.

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