The Drugs Controller General of India (DCGI), has cleared Itolizumab, a drug used to treat severe chronic plaque psoriasis, for restricted emergency use in COVID-19 care.
The DGCI’s approval for Itolizumab is for emergency use only in the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to COVID-19, biopharmaceuticals firm Biocon said. The company said Itolizumab will be manufactured and formulated as an intravenous injection at the bio-manufacturing facility in Bengaluru.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. The DCGI nod for the repurposed drug is based on results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.
The decision comes as the Health Ministry said that available evidence for remdesivir suggests that it may decrease the time for clinical improvement when used in moderate to severe cases and has no benefits in terms of reduced mortality.
“Remdesivir has to be used with extreme caution due to its potential for serious adverse effects including liver and kidney injury,” the Ministry said.
It added that studies on another drug, Tocilizumab, have not shown any benefits in mortality reduction. “Rampant use is to be discouraged since the effect of the drug is directed at the ‘cykotine storm’,” the Ministry added.
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