Biocon’s drug Itolizumab gets DCGI Nod for treatment of moderate to severe COVID patients

In a major breakthrough in the treatment of Coronavirus in India, Biocon's drug Itolizumab received a nod by the Drugs Controller General of India (DCGI) for its use on moderate to severe COVID-19 patients. The leading pharmaceutical company's drug is one of the first biologic therapy drugs to be approved for the treatment of COVID patients across the world. It will be available in the form of an intravenous injection. 

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 added. The drug will be manufactured and formulated as an intravenous injection at the company''s bio-manufacturing facility at Biocon Park, Bengaluru.

According to Biocon's statement, 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 CRS in moderate to severe ARDS 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, leading to a successful trial.  Itolizumab will be manufactured domestically in Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.

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“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. The data is compelling and I am 2 confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country," said Founder and Chairperson of Biocon Kiran Mazumdar-Shaw.

DCGI''s approval for Itolizumab is based on the results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi, Biocon said. Last week, DCGI had also given a green signal for conducting the human trials of India's first COVID-19 vaccine 'Covaxin'. Covaxin has been approved for Phase I & II Human Clinical Trials which will begin from July.

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