"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 confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country. 

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 cytokine release syndrome (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. 

ALZUMAb  has a seven-year proven track record of safety as doctors in India have been prescribing this biologic to treat acute psoriasis and ensure a better quality of life for patients and now we will be able to save many critically ill COVID-19 patients with our drug.” 

- Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, Bengaluru