The Drug Controller General of India (DCGI) granted its permission to Itolizumab injection for the restricted emergency use on COVID-19 patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to virus.
The top drug regulator Dr VG Som on Friday gave his green signal for Itolizumab injection--a recombinant anti-CD6 monoclonal antibody for the restricted emergency use on COVID-19 patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS).
Itolizumab injection is already approved drug of Biocon Ltd used for the treatment of patients with active moderate to severe chronic plaque psoriasis for the last many years.
"After clinical trials on coronavirus patients in India, the drug was found satisfactory by the subject expert committee consisting of pulmonologist, pharmacologist, medicine experts from AIIMS etc and it is cleared for restricted emergency use for the treatment of cytokine release syndrome (CRS) on COVID-19 patients with moderate to severe acute respiratory distress syndrome (ARDS)," said the official.
Doctors have to get the consent-form duly filled by the patient in a prescribed manner before using the drug.
Besides this, the pharma company i.e. Biocon Ltd has to follow up each and every patient's case with regard to safety and efficacy of the drug to whom this drug is being administered, said the official adding that the pharma company has to conduct the post-marketing trial etc.
( With inputs from ANI )