DCGI nod for restricted emergency use to Itolizumab for moderate to severe COVID-19 patients
New Delhi, July 13, 2020
Itolizumab (rDNA origin), a monoclonal antibody, already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation by the Drugs Controller General of India (DCGI) based on clinical trials data, an official press release from the Ministry of Health & Family Welfare said here on Saturday.
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, the release said.
Biocon has presented the Phase II clinical trial results generated in COVID-19 patients to DCGI. The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office.
Details of the 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.
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 the hospital set up only etc.
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, the release added.