Health

Biocon to launch drug for COVID-19 patients; priced at Rs 8,000 per vial

Kiran Mazumdar Shaw, CEO of Biocon Limited, announced on Monday that he received approval from the General Drug Controller of India (DCGI) to market the Itolizumab 25mg / 5ml injection solution (ALZUMAb) for emergency use in India for the treatment of moderate to severe cytokine release syndrome (CRS) in patients with ARDS (acute respiratory distress syndrome) due to COVID-19.

Kiran Mazumdar Shaw, CEO of Biocon Limited, Bangalore, announced on Monday that he has received approval from the General Drug Controller of India (DCGI) to market the Itolizumab 25mg / 5ml injection solution (ALZUMAb) for use by emergency in India for the treatment of cytokine release. syndrome (CRS) in patients with ARDS (acute respiratory distress syndrome) of moderate to severe due to COVID-19.

Itolizumab is the first new biologic therapy approved anywhere in the world for the treatment of patients with moderate to severe COVID-19 complications. Biocon has reused Itolizumab, an anti-CD6 IgG1 monoclonal antibody released in India in 2013 as ALZUMAb® for the treatment of chronic plaque psoriasis, for the treatment of CRS in patients with moderate to severe ARDS due to COVID-19.

Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility in Biocon Park, Bengaluru.

DCGI’s approval of Itolizumab is based on the results of the successful conclusion of a randomized, controlled clinical trial in various hospitals in Mumbai and New Delhi. The study focused on the safety and efficacy of Itolizumab in preventing CRS in patients with moderate to severe ARDS due to COVID-19.

Primary end points for mortality reduction were reached and other key secondary end points for efficacy and biomarkers were also reached. More than 100 people in Maharashtra, Gujarat and Delhi have been cured and received the drug Itolizumab.

Speaking of development, Kiran Mazumdar Shaw said: “As an innovation-led biopharmaceutical company, I am proud of the successful outcome of the fundamental study we conducted with our new anti-CD6 immuno-modulating monoclonal antibody, Itolizumab, which has been shown to be an intervention effective in treating the severe hyperimmune response seen with COVID-19. The data is compelling and I am too confident that this ‘first of its kind’ biologic will save lives and help reduce the death rate in our country.”

Kiran Mazumdar Shaw further stated: “This positions India among the world’s leading innovators in its effort to overcome the COVID-19 pandemic. The randomized control trial indicated that all 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 bring this therapy to other parts of the world affected by the pandemic. ”

“Itolizumab’s unique mechanism of action made it an ideal candidate for the treatment of ‘cytokine storm’, which is the leading cause of death in patients with COVID-19. I am pleased that our clinical and R&D teams have fulfilled this promising hypothesis in such a short time. It is a moment of pride for all of us at Biocon and we would like more and more patients to benefit from this therapy. I also thank the researchers and regulators for the sense of urgency they showed at this study, “Shaw added.

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