India's drug regulator has approved Itolizumab, a drug used to cure skin ailment psoriasis for "restricted emergency use" to treat COVID-19 patients with moderate to severe acute respiratory distress, officials said.
Considering the unmet medical needs to treat COVID-19, Drugs Controller General of India, Dr V G Somani, approved monoclonal antibody injection Itolizumab, an already approved drug of Biocon, for restricted emergency use for the treatment of ‘cytokine’ release syndrome in moderate to severe acute respiratory distress syndrome patients due to COVID-19, they said.
"The approval was given after its clinical trials on COVID-19 patients in India was found satisfactory by the expert committee comprising pulmonologists, pharmacologists and medicine experts from AIIMS, among others, for treatment of cytokine release syndrome,” an official told PTI.
"It is already an approved drug of Biocon for treating psoriasis for the last many years," the official said.
Written informed consent of each patient is required before the use of this drug, he said.