DGCI has given ‘restricted emergency use’ approval to the drug for treating Covid-19 patients with moderate-to-severe acute respiratory distress.
By Mohana Basu – Jul 12, 2020
New Delhi: The Drug Controller General of India (DGCI) has given “restricted emergency use” approval to Itolizumab, a drug used to cure skin ailment psoriasis, for treating Covid-19 patients with moderate-to-severe acute respiratory distress.
Itolizumab is a ‘humanised monoclonal antibody’ developed by the Bangalore-based biopharmaceutical company, Biocon, in collaboration with the Center for Molecular Immunology (CIM) in Cuba.
Monoclonal antibodies are antibodies produced by immune cells that are cloned from one parent immune cell. These antibodies are designed to bind to a specific type of proteins.
In the case of Itolizumab, it selectively targets CD6, a protein found in the outer membrane of T-cell. T-cell is a type of white blood cell that plays a central role in the body’s immune response.
Protein CD6 is important for the continued activity of T-Cells when the body encounters a foreign pathogen.
However, in case of the Covid-19 infection, sometimes the immune system goes into an overdrive — a process known as cytokines storm — causing inflammation and organ damage.
Itolizumab, by binding to CD6, down regulates T-cell activation, and causes reduction in synthesis of pro-inflammatory cytokines.
The drug has previously been shown to be effective for treating psoriasis, an autoimmune disease in which skin cells build up and form scales and itchy, dry patches.
Biocon had started developing the molecule in collaboration with the Centre for Molecular Immunology (CIM). The company’s scientific team then started developing the antibody for auto-immune diseases in 2006 in India.
Conduct further clinical trials: Health ministry
Biocon received approval for the drug from the DCGI in January 2013.
In May, the company received permission from DGCI to repurpose the drug for Covid-19 treatment.
The trials of the drug were conducted in New Delhi, Mumbai and Bengaluru.
The health ministry has recommended that Biocon must continue to conduct further clinical trials of the drug and also submit a risk management plan to address the safety issues in the post marketing scenario, ThePrint has learnt.
A written, informed consent needs to be obtained from every patient before the drug is administered to the patient. The informed consent form should have factual details about the drug as well as details about alternative therapies available.
According to the documents accessed by ThePrint, the health ministry recommends that the drug can be supplied only on the prescription of a medical specialist and should only be used in hospital settings.