New Delhi: Biotechnology major Biocon on Saturday announced that its “breakthrough drug,” Itolizumab has received Drugs Controller General of India’s (DCGI) approval for use on COVID-19 patients, with moderate to severe acute respiratory distress syndrome.
DCGI has approved to market Itolizumab (ALZUMAb) 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.
It said Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications.
“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.
Itolizumab injection is already an approved drug of Biocon Limited used for the treatment of patients with active moderate to severe psoriasis.
