Published 18:59 IST, July 26th 2020
COVID-19: Health ministry decides not to put Itolizumab in national treatment protocol
The National Task Force on COVID-19 has decided against including Itolizumab drug in clinical management protocols for treating the disease
Advertisement
The National Task Force on COVID-19 has decided against including Itolizumab drug in clinical management protocols for treating the disease. The DCGI has approved its "restricted emergency use" in infected patients, official sources said.
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.
The permission to market the drug was granted for the treatment of cytokine release syndrome in ‘moderate’ to ‘severe’ Acute Respiratory Distress Syndrome patients due to COVID-19.
"The issue of including the drug in the clinical protocols was discussed in a meeting held on Friday. A majority of the members of the task force opined that there was not enough evidence currently to get the drug included in the clinical management protocols for COVID-19," said an official source.
Earlier, 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.
India's COVID-19 tally soars to 13,85,522 with 48,661 fresh cases
With 48,661 people testing positive for coronavirus infection in a day, India's COVID-19 tally climbed to 13,85,522 on Sunday, while the recoveries mounted to 8,85,576, according to the Union Health Ministry data. The country's death toll rose to 32,063 with 705 fatalities being recorded in a day, the data updated at 8 am showed. There are 4,67,882 active cases of coronavirus infection presently in the country. Thus, around 63.92 per cent people have recovered so far. The total number of confirmed cases includes foreigners.
(With Inputs from Agencies)
18:59 IST, July 26th 2020