Chennai: Drugs Controller General of India has approved Itolizumab (rDNA origin) for treatment of moderate to severe Covid.
Itolizumab is a monoclonal antibody which was already approved for severe chronic plaque psoriasis, an autoimmune skin disease. The drug has now been granted restricted emergency use authorisation by the DCGI, based on ‘clinical trials’ data.
In a statement, the Health Ministry said, “After detailed deliberation and taking into account the recommendations of the Committee (subject expert committee), DCGI has decided to grant permission to market the drug under Restricted Emergency Use of the drug for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients due to COVID-19, subject to some conditions like informed consent of patients, a risk management plan, and to be used in hospital set up only etc.”
The Ministry said Biocon has presented the Phase II clinical trial results generated in Covid-19 patients to the DCGI. The results of these trials were deliberated by the Subject Expert Committee.
“Details of primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNFα etc., were presented to have reduced significantly with the drug thereby preventing hyper- inflammation in Covid-19 patients,” it added.