‘Itolizumab’ Injection gets DCGI Approval for Treatment of Moderate to Serve ARDS Patients
The Drug Controller General of India (DCGI) has given its approval to ‘Itolizumab’ injection for the treatment of COVID-19 patients with restricted emergency use only in case of moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients.
DCGI has made it clear that written informed consent of the patient will be required by the authorities before administrating the Itolizumab injection.
Clinical Trials with Itolizumab
The approval by the DCGI was given after satisfactory outcomes during the clinical trials conducted by the Expert Committee from All India Institute of Medical Science (AIIMS) on COVID-19 patients.
Itolizumab is an anti-CD6 monoclonal antibody injection that is being used in India for the treatment of Psoriasis (Skin Disorder in which Skin Cells multiply 10 times faster than normal).
Bengaluru based biopharmaceutical company- Biocon Limited is the developer and the manufactures of the Itolizumab injection. Biocon’s Itolizumab got approval from the DCGI for the treatment of Psoriasis back in January 2013.