Raising questions on the efficacy of Itolizumab and Tocilizumab drugs in Covid-19 treatment, Dr Balram Bhargava, Director-General of the Indian Council of Medical Research (ICMR), on Tuesday said neither drug had demonstrated reduction in mortality and so more trials are needed.
Bhargava’s statement at a government press briefing comes just a day after Biocon Ltd touted its Psoriasis drug Itolizumab as a potentially life-saving drug.
In a public webinar on Monday, the company had claimed that following a small clinical trial comprising 30 people, the drug showed mortality reduction in the intervention arm among 20 people. The Drug Controller General of India (DCGI) had granted ‘emergency use authorisation’ for the drug which will cost Rs 8,000 a vial and Rs 32,000 to complete a full course of therapy, as per the company.
During the press briefing, Bhargava was asked about the off-label use of Itolizumab by doctors in various parts of the country. Off-label use refers to use of a drug in a treatment that it is not originally been approved for by regulators.
Bhargava said, “In severe patients of Covid, there is a problem of a cytokine storm. Cytokines are released and they are responsible for a storm which ultimately leads to serious conditions. There are two drugs which have been, thought to be preventing the Cytokine storm. One is Tocilizumab and the other is Itolizumab, which are being thought that they can prevent the cytokine storm.”
Expanding on their efficacy, Bhargava said, “Having said that, they have not yet demonstrated mortality reduction by any trial and therefore trials are wanting and are happening in different parts of the world to look at whether there is mortality reduction with these two drugs.”
A cytokine release storm leads to heightened activity of the immune system to fight infections. However, it may harm the body if the immune reaction goes out of control and affects lungs and other organs. Itolizumab is touted as a drug that prevents the cytokine storm.
News18.com has sought Biocon’s response to Bhargava's comments. The firm should conduct Phase IV clinical trial study of the subject drug.
On Twitter, responding to queries on the ICMR-DG’s comments, Biocon’s Executive Chairperson Kiran Mazumdar-Shaw said, “Dr Bhargava is right. We have received Emergency Use Authorisation on a small pivotal trial. As mandated, we will do a larger Ph4 clinical trial n we also have 150 pt real world ‘off label’ data which will be published (sic).”
Shaw was referring to patients who were treated with the drug prior to DCGI’s approval as part of the off-label usage. While granting emergency use approval, the drug regulator also asked the company to conduct Phase – IV clinical trial study of Izolitumab.