Biocon drug gets regulator nod for treating Covid patients

BENGALURU: Biocon said it received approval from the Drugs Controller General of India (DCGI) to use its biologic Itolizumab for Covid-19 patients in critical and moderate situations.
The drug is the first novel biologic therapy to be approved anywhere in the world for treating patients with such complications. The drug, used to treat psoriasis, a skin condition, was commercialised in India in 2013.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.
“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. We plan to take this therapy to other parts of the world impacted by the pandemic,” said executive chairperson Kiran Mazumdar-Shaw.
The approval of Itolizumab from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi. The study focussed on the safety and efficacy of Itolizumab in preventing cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to Covid. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.
The SARS-CoV-2 virus has been observed to induce an overreaction 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.