Biopharmaceutical major Biocon Ltd said on Saturday it has received approval from the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/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.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications, it said.
Biocon has re-purposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb for treating chronic plaque psoriasis for the treatment of CRS in moderate to severe ARDS patients due to Covid-19.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon's bio-manufacturing facility at Biocon Park in Bengaluru.
The SARS-CoV-2 virus has been observed to induce an over-reaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs, and, in the worst scenario, multi-organ failure and even death.
Biocon said the approval of Itolizumab from the DCGI is based on the results from the successful conclusion of a randomised, 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.
The primary end-points for a reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.
"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 hyperimmune response seen with Covid-19," said Biocon Executive Chairperson Kiran Mazumdar Shaw.
"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 among the leading global innovators in their effort to overcome the Covid-19 pandemic. The randomised control trial indicated that all the patients treated with Itolizumab (ALZUMAb) responded positively and recovered."
Shaw said 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 take this therapy to other parts of the world impacted by the pandemic."
( With inputs from ANI )