Biocon’s Itolizumab Gets DCGI Approval For COVID-19 Treatment
The Drugs Controller General of India (DCGI) approved the use of Biocon’s biologic drug Itolizumab for the treatment of moderate to severe novel coronavirus patients. Biocon said in a BSE filing that DCGI had approved the use of Itolizumab injection 25mg/5mL solution in India for emergency treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) seen during novel coronavirus infection.
This is the first time a new biologic therapy is being approved in the world to treat moderate to severe COVID-19 patients.
But the price at which the drug will be sold has not been disclosed by the company. The anti-CD6 IgG1 monoclonal antibody drug was previously launched in India as Alzumab in 2013 to treat chronic plaque psoriasis, which is now repurposed by Biocon for COVID-19 treatment.
The Biocon Park in Bengaluru, where the bio-manufacturing facility of Biocon is situated, will manufacture and formulate Itolizumab as an intravenous injection.
Itolizumab had successfully completed the randomized, controlled clinical trial at multiple hospitals in New Delhi, and Mumbai based on which the DCGI approved it for COVID-19.
Kiran Mazumdar-Shaw, the executive chairperson at Biocon, said she is proud of the successful completion of the study they conducted to test the efficiency of Itolizumab, the novel immuno-modulating anti-CD6 monoclonal antibody, in the treatment of hyperimmune responses commonly seen in COVID-19 patients.
This has made India one of the leading investors in the world who are trying to fight the COVID-19 pandemic.
Mazumdar-Shaw added that the company is planning to expand this therapy to other countries struggling with the pandemic.
So far, India has reported 878,254 cases, with 23,174 deaths. India is currently the third most affected country following the US and Brazil. Delhi, Maharashtra, and Tamil Nadu are the worst-hit states in India.