Even as the Drugs Controller General of India (DCGI) has given permission to Itolizumab drug for restricted emergency use on moderate to severe COVID-19 patients, the Union Health Ministry has decided not to include the drug in the national treatment protocol for coronavirus patients.
In the recent past, the National Task Force on COVID-19 constituted by the Health Ministry held its meeting and discussed whether to put Itolizumab drug into the treatment protocol or not.
"It was discussed in the meeting but it is not included for now because experts opine very less evidence in favour of this medicine," said a senior Health Ministry official.
On July 11, the Health Ministry in a press statement said that Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation by the DCGI based on clinical trials data.
The ministry further stated that Biocon has been manufacturing and marketing the Itolizumab 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 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," said the Health Ministry.
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, TNFa, etc., were presented to have reduced significantly with the drug thereby preventing hyper- inflammation in COVID-19 patients, noted the press note.
The average cost of treatment with this indigenous drug i.e Itolizumab is also lesser than comparable drugs which are part of the "Investigational Therapies" indicated in the Clinical Management Protocol for COVID-19 of the health Ministry, it said.
( With inputs from ANI )