The Drug Controller General of India (DCGI) has given a nod to Biocon’s plaque psoriasis drug - Itolizumab - for “restricted emergency use” for COVID-19 patients, who show moderate to severe acute respiratory issues.
This ‘humanised monoclonal antibody’ has been developed by Bangalore-based biopharmaceutical company Biocon in association with the Centre for Molecular Immunology (CIM) in Cuba, and was first approved by DCGI in 2013.
As the name suggests, monoclonal antibodies are produced by immune cells that are cloned from one parent immune cell. Besides, these antibodies bind to the CD6 receptor and block the activation of T-cell ( a type of white blood cell) that helps in suppressing inflammatory cytokines in the body.
Protein CDG is critical for the consistent activity of T-cells, especially when the body comes across a foreign body. But when the body suffers from Coronavirus, the immune system goes into an overdrive mode, in the form of a cytokines storm that is likely to cause inflammation and organ damage.
In an interview to a media publication, Biocon executive chairperson Kiran Mazumdar-Shaw said, “Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm,’ which is a leading cause of death in COVID-19 patients.”
The drug has been earlier utilised in the treatment of psoriasis, an autoimmune disease that causes build-up of skin cells and shows up in the form of patches.
Clinical trials by Health Ministry
It was in May that Biocon received an approval from DCGI to repurpose the drug for the use of COVID-19. The trials of the drug were conducted in New Delhi, Mumbai and Bengaluru.
The Ministry of Health has suggested that Biocon must conduct further clinical trials of the drugs, and must also submit a risk management plan to address the safety issues in the post marketing scenario, according to The Print.
Whenever the drug is being administered to a patient, a consent form must be mandatorily signed by the receiver before the process begins. The consent form must contain all the factual details about the drug as well as details about alternative therapies available.
Lastly, the Ministry has issued a mandate that the drug can only be supplied based on the prescription of a medical specialist and should only be used in hospital settings.
(Edited by Athira Nair)