The injection can be administered only after taking the informed consent from the patient, said DGCI
New Delhi: 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 told PTI on Friday.
Considering the unmet medical needs to treat COVID-19, Drugs Controller General of India, Dr VG 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.
India's COVID-19 case count crossed the eight lakh-mark on Saturday with yet another highest single-day spike of 27,114 new cases in the last 24 hours. As many as 519 deaths were reported during this period.
The total number of cases in the country stands at 8,20,916, including 2,83,407 active cases, 5,15,386 cured/discharged/migrated and 22,123 deaths, according to the ministry of health and family welfare.
Last Updated 11, Jul 2020, 6:48 PM