DCGI gives nod for 'restricted emergency' use of Itolizumab injection on COVID-19 patients

New Delhi: The Drug Controller General of India (DCGI) granted permission for the 'restricted emergency' use of Itolizumab injection on moderate to severe COVID-19 patients amid the rising number of cases across India. The DCGI gave approval to the use of this injection on COVID-19 patient based on clinical trials data.

Itolizumab (rDNA origin) is a monoclonal antibody that is already an approved drug of Biocon for severe chronic plaque psoriasis. Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab. 

Biocon has presented the Phase II clinical trial results generated in COVID-19 patients to DCGI. 

The DCGI statement said, ''after detailed deliberation and taking into account the recommendations of the 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, to be used in hospital set up only etc.''

This indigenous drug has now been repurposed for COVID-19.

The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office.

The average cost of treatment with this indigenous drug i.e Itolizumab is lesser than comparable drugs which are part of the 'Investigational Therapies' indicated in the Clinical Management Protocol for COVID-19 of the Ministry of Health and Family Welfare.