Even as Biocon's Itolizumab has been approved for emergency use in treatment of critical COVID-19 patients, the National Task Force on COVID-19, has not added it to the national clinical management protocols, citing lack of evidence on the drug.
The National Task Force on COVID-19, under the Ministry of Health that recommends certain protocols for the management of COVID-19 and its spread, has raised concerns over the size of the phase 2 clinical trials sample and raised concerns over the fact that phase 3 trials have been waived off by the Drugs Controller General of India.
DCGI approved Itolizumab based on a 30-patient phase 2 clinical trial, which has been approved as a treatment for psoriasis.
In the absence of other global trials, the task force has said that more studies need to be conducted to find out if generalised immunosuppressants like Itolizumab can be counter-productive. For now the task force has said not enough evidence is available, hence it cannot be included in clinical management guidelines.Watch the video for more.