NEW DELHI: Itolizumab, an indigenous drug used to treat skin disease called Psoriasis, has become the latest drug authorised for the emergency use to treat moderate to severe Covid-19 patients after initial clinical trials indicated that the medicine relieves cytokine storms.
Cytokine storms or acute inflammatory response in infected patients have been identified as the leading cause of death in Covid-19 patients.
The Drug Controller General of India (DCGI) on Saturday approved the drug for use in coronavirus patients after the results of phase II clinical trials of the drug, carried out in Delhi and Mumbai, were scrutinised by its subject expert committee and were found to be "satisfactory."
The monoclonal antibody medicine Itolizumab, which is administered through injection and costs Rs 7,500 per box, was launched by Biocon seven years ago under the brand name Alzumab and was touted as the second novel biological drug developed entirely in India.
A statement by the Central Drug Standards Control Organisation (CDSCO) on Saturday indicated that with the administration of the medicine, key inflammatory markers IL-6 and TNFα among others were found to have reduced significantly 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 in moderate to severe acute respiratory distress syndrome patients due to Covid-19,” the CDSCO release said.
The regulator, so far, however, has not made public the full findings and details of the study based on which the approval has been issued.
The use of the medicine for the infectious disease, however, will have some conditions such as informed consent of patients and a risk management plan.
The regulator also underscored that 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 by the Union health ministry.
The regulator has granted the same approval to drugs such as Remdisivir and Tocilizumab - both of which have seen exorbitant price rise in the past few weeks owing to black marketing.