Drug regulator okays psoriasis injection for restricted emergency use in treating COVID-19 patients

Aditi Tandon

Tribune News Service

New Delhi, July 11

Itolizumab, a monoclonal antibody drug being used in India to treat severe chronic plaque psoriasis — a skin condition — has now been granted the Restricted Emergency Use authorisation by the Drugs Controller General of India (DCGI) for administration to moderate and severe COVID-19 patients.

Pharma firm 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.

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

Biocon presented the Phase II clinical trial results generated in the COVID-19 patients to the DCGI. The results of these trials were deliberated in the Subject Expert Committee of the DCGI’s office.

The details of the primary endpoint of mortality and other key endpoints of lung function such as improvement in oxygen saturation were presented. Key inflammatory markers were presented to have reduced significantly with the drug thereby preventing hyper-inflammation in COVID-19 patients.

After detailed deliberation and recommendations of the committee, the 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 such as informed consent of patients and a risk management plan to be used in the hospital setup only.

The drug will not be available off the shelf.

The average cost of treatment with this indigenous drug is also 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.