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DCGI has vowed to market Itolizumab (ALZUMAb) injection 25mg and 5mL solution for emergency usage within India for the cure of cytokine release syndrome (CRS) at moderate to severe ARDS (acute respiratory distress syndrome) patients thanks to COVID-19, Biocon said in a release.
It said Itolizumab is your first publication biologic therapy to become approved around the globe for treating patients having mild to severe COVID-19 complications.
Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India at 2013 as ALZUMAb for curing chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19, it included.
Itolizumab will be fabricated and formulated as a intravenous injection at Biocon’s bio-manufacturing centre at Biocon Park here.
“I’m proud of this successful outcome of this critical study we ran together with our book immuno-modulating anti-CD6 monoclonal antibody,” Itolizumab, that has been shown to be an efficacious intervention in treating the significant hyper-immune response seen by COVID-19. The data remains compelling and I am convinced that this first-in-class biologic helps you to save lives and help reduce the mortality rate in our country,” Biocon Executive Chair Person Kiran Mazumdar Shaw said.
Noting this positions India one of the top worldwide innovators within their attempt to over come the COVID-19 pandemic, she said, the randomized control trial signaled that most the patients treated using Itolizumab (ALZUMAb) reacted favorably and recovered.
Itolizumab has become qualified for the treatment of CRS in patients who have moderate to severe ARDS on account of COVID-19. We plan to take this therapy to all other sections of the world affected by the pandemic, ” she added.
Biocon reported the endorsement of Itolizumab from the DCGI is based on the outcomes from the successful completion of a randomized, controlled clinical trial in multiple hospitals at Mumbai and New Delhi.
The study focussed on the efficacy and safety of Itolizumab in preventing CRS at moderate to severe ARDS patients due to COVID-19, he said adding that the principal endpoints for lowering of mortality rate were fulfilled along with other key secondary endpoints for efficiency and biomarkers have been likewise achieved.
