Kiran Mazumdar Shaw, Executive Chairperson of Biocon Limited, Bengaluru, announced Monday that it 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.
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.
The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved. Over 100 people in Maharashtra, Gujarat and Delhi have been cured who were given Itolizumab drug.
Speaking on the development, Kiran Mazumdar Shaw said, "As an innovation-led biopharmaceuticals company, 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 too confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country."
Kiran Mazumdar Shaw further said, “This positions India amongst the leading global innovators in their effort to overcome the COVID-19 pandemic. The randomized control trial indicated that all the patients treated with Itolizumab (ALZUMAb®) responded positively and recovered. The control arm that did not receive Itolizumab unfortunately had deaths. 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."
“Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in COVID-19 patients. I am pleased that our R&D and clinical teams delivered on this promising hypothesis in such a short period of time. It is a proud moment for all of us at Biocon and we would like more and more patients to benefit from this therapy. I also thank the investigators and the regulators for the sense of urgency that they displayed in this study," Shaw added.