Drugs Controller General of India’s (DCGI) has given its nod to Biotechnology major Biocon to use its “breakthrough drug,” Itolizumab in moderate to severe COVID-19 patients. India’s drug regulator has approved to market Itolizumab (ALZUMAb) injection 25mg and 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, Biocon said in a release.
It said Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe coronavirus 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, it added.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park.
“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.
Noting that this positions India amongst the leading global innovators in their effort to overcome the COVID-19 pandemic, she said, the randomized control trial indicated that all the patients treated with Itolizumab (ALZUMAb) responded positively and recovered.
Itolizumab is now approved for the treatment of CRS in patients with moderate to severe ARDS due to COVID-19. We plan to take this therapy to other parts of the world impacted by the pandemic, she added. 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.