India’s Biocon has received approval from the country’s drug regulator to market, Itolizumab injection, to treat cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) in COVID-19 patients, a company statement said.
In 2013, Biocon had launched Itolizumab, an anti-CD6 IgG1 monoclonal antibody biologic therapy for treating chronic plaque psoriasis, which it has now repurposed for treating COVID-19 patients.
The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs.
The virus can cause, in the worst scenario, multi-organ failure and even death.
The approval of Itolizumab from the drug regulator is based on the results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi, the statement said.
India, ranked third after the United States and Brazil for the number of confirmed COVID-19 cases in the world, has 283,407 active cases with 22,123 deaths reported so far.