New Delhi, July 11 (IANS) The Drugs Controller General of India (DCGI) has okayed the use of Itolizumab (rDNA origin), a monoclonal antibody, for the treatment of moderate to severe COVID-19 patients.
The indigenous drug, which was already approved for severe chronic plaque psoriasis, has now been repurposed for the treatment of COVID-19 patients with “restricted emergency use” based on clinical trials. Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under the brand name Alzumab.
The DCGI gave permission for the use of the Itolizumab drug after Biocon presented the Phase-II clinical trial results generated in COVID-19 patients.
“The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office,” the Ministry of Health and Family Welfare (MoHF) said. “Details of 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, TNFI 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, the DCGI has decided to grant permission to market the drug under “restricted emergency use” for the treatment of “Cytokine Release Syndrome A(CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients due to COVID-19. This is subject to some conditions like informed consent of patients, a risk management plan, to be used in hospital set up only, the Ministry said.
The average cost of treatment with Itolizumab is also less than comparable drugs which are part of the “Investigational Therapies” indicated in the Clinical Management Protocol for COVID-19 of the MoHFW.
The drug gets the nod to be used for novel coronavirus or COVID-19 infected patients in “restricted emergency use” at a time when a total of 8,20,916 confirmed cases have been reported across the country as per the latest MoHFW data. Of them, 5,15,385 patients have recovered while 2,83,407 remain active. However, 22,123 deaths have been reported till now.