On Saturday, Biotechnology major Biocon announced that their drug Italizumab had got DCGI permit for its usage in COVID-19 patients with moderate to severe symptoms.
For an emergency usage of this drug in Inda, DCGI has approved to market 25 mg and injection and 5ml solution of Itolizumab said Biocon in a release.
For treating COVID-19 infection Itolizumab globally is the first biologic therapy to treat COVID-19 patients with moderate to severe symptoms.
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, it added.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park here. “I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with COVID-19. The data is compelling and I am confident that this first-in-class biologic will save lives and help reduce the mortality rate in our country,” Biocon Executive Chairperson Kiran Mazumdar-Shaw said.
After this permission, India belongs to the leading global innovators to overcome the pandemic.
Biocon Executive added that they plan to forward this therapy to the countries affected by the pandemic globally. Biocon said 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.
The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19, he said adding that the primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.