ALZUMAb (Itolizumab) from Biocon receives the Drug Controller General of India (DCGI) approval for use in moderate to severe COVID-19 patients.
A Bangalore based biopharmaceutical company got the approval from Drug Controller General of India (DCGI) for the medicine ALZUMAb (Itolizumab) is a breakthrough drug used in moderate to severe covid-19 patients. ALZUMAB (Itolizumab) injection 25mg and 5ml solution has been approved by DCGI for marketed in case of emergency patients in India is used in the treatment of moderate to severe covid-19 patients. DCGI has approved to market ALZUMAb (Itolizumab) 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.
According to the statement of Biocon released, Alzumab is the first Novel biologic therapy in the world approved for the patients to treat with moderate to severe COVID-19 patients. Originally the Alzumab an anti-CD6 IgG1 monoclonal antibody got the approval in 2013 January for the treatment 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 in Bengaluru.
"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