: Coronavirus: Task force decides not to recommend Biocon’s itolizumab for treatment, say reports #IndiaNEWS The National Task Force on the coronavirus pandemic has decided not to recommend the drug

Coronavirus: Task force decides not to recommend Biocon’s itolizumab for treatment, say reports #IndiaNEWS
The National Task Force on the coronavirus pandemic has decided not to recommend the drug itolizumab in the national protocol for treating the Covid-19 infection for now, The New Indian Express reported on Sunday. The drug was struck down as a treatment option at a meeting on Friday, as most members of the task force felt the evidence cited in favour of the medicine is “inconclusive???. Itolizumab, developed by Bengaluru-based Biocon Limited, was approved by the Drug Controller General of India earlier this month, to treat patients with moderate to severe acute respiratory distress. It was cleared after a randomised clinical trial of only 30 patients. The move was widely criticised by health experts who said that 30 is a very small number of participants for a phase 2 clinical trial – too small to lend itself to a statistically significant outcome. Later, it also emerged that the Central Drug Standards Control Organisation had waived the need to conduct phase 3 trials while clearing Itolizumab for Covid-19 patients. “There was a long discussion on itolizumab but most members felt that there is no substantial evidence yet to include it in the national Covid-19 clinical management guidelines,??? unidentified officials from the task force told The New Indian Express. The task...Read more

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