Biocon gets DCGI nod to use Itolizumab in moderate to severe Covid-19 patients

Bengaluru: Biocon's drug Itolizumab has been approved by the Drugs Controller General of India (DCGI) for treating moderate to severe Covid-19 patients.
The Bengaluru-headquartered pharma company said it has received DCGI nod to market Itolizumab (ALZUMAb) Injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) due to Covid-19.

Biocon said the approval is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.

The drug inhibits the production of pro-inflammatory cytokines, proteins released by cells. Cytokine storm is a complication of Covid-19.

The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe acute respiratory distress syndrome patients due to Covid-19.

The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.

Itolizumab, which was launched in India in 2013 for treating skin disease and recently repurposed, is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications, said the company.

“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 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," said Kiran Mazumdar-Shaw, executive chairperson, Biocon.