Chief biotechnology specialist Biocon announced on Saturday that its “breakthrough drug”, Itolizumab, received approval from the General Drug Controller of India (DCGI) for use in patients with moderate to severe COVID-19.
DCGI has approved the marketing of 25 mg Itolizumab solution (ALZUMAb) and a 5 ml solution for emergency use in India for the treatment of moderate to moderate cytokine release syndrome (CRS) in patients with ARDS. severe due to COVID-19, Biocon said in A Launch.
He said Itolizumab is the first novel biological 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 to treat chronic plaque psoriasis, for the treatment of CRS in patients with moderate to severe ARDS due to COVID-19, it added.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility in Biocon Park here. “I am proud of the successful outcome of the pivotal study we conducted with our new anti-CD6 immuno-modulating monoclonal antibody, Itolizumab, which has been shown to be an effective intervention in treating severe hyperimmune response seen with COVID-19. The data is compelling. And I am sure that this first class biological will save lives and help reduce the mortality rate in our country, “said Biocon CEO Kiran Mazumdar-Shaw.
Noting that this ranks India among the world’s leading innovators in its effort to overcome the COVID-19 pandemic, he said, the randomized control trial indicated that all Itolizumab (ALZUMAb) -treated patients 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 bring this therapy to other parts of the world affected by the pandemic,” he added. Biocon said that the approval of Itolizumab by DCGI 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, he said, adding that the primary endpoints for reducing the death rate and other conditions were also met. Key secondary endpoints for efficacy and biomarkers. accomplished.