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

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

Itolizumab is first vel biologic rapy to be approved anywhere in world for treating patients with moderate to severe COVID-19 complications, it added. drug will be manufactured and formulated as an intraveus injection at company''s bio-manufacturing facility at Biocon Park, Bengaluru.

According to Biocon's statement, approval of Itolizumab, from DCGI is based on results from successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi. study focussed on safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19.

primary endpoints for reduction in mortality rate were met and or 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 invation-led biopharmaceuticals company, I am proud of successful outcome of pivotal study we conducted with our vel immu-modulating anti-CD6 moclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating serious hyperimmune response seen with COVID-19. data is compelling and I am 2 confident that this ‘first-in-class’ biologic will save lives and help reduce mortality rate in our country," said Founder and Chairperson of Biocon Kiran Mazumdar-Shaw.

DCGI''s approval for Itolizumab is based on results from 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 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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