(Daily News Scan - DNS English) What is Itolizumab Drug?
In one of our DNS we had let you know the drugs India is using to fight coronavirus. In that we had told you about the drug – Itolizumab. It is a drug that is used commonly for skin disorder psoriasis, rheumatoid arthritis, multiple sclerosis, and autoimmune disorders. Now, the Drug Controller General of India has approved it as a therapy for restricted emergency use to treat Covid -19 patients. But this decision has created a controversy due do the small size of the clinical trials, and because exemption has been granted from phase-III trials.
In this DNS we will talk about the drug Itolizumab.
Itolizumab is an existing drug used for psoriasis, a chronic skin disease involving unregulated growth of some skin cells that develop into red patches mostly on knees and elbows, but also on some other parts of the body. It is considered safe and effective for the treatment of psoriasis. It was launched in India by Biocon in the year 2013.
This drug has been permitted to use in emergency situations. The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, causing severe damage to the lungs and other organs, in the worst cases, multi-organ failure and even death.
The approval from the DCGI is based on the results from the conclusion of a randomised, controlled clinical trial at hospitals in Mumbai and New Delhi. The study focused on the safety and efficacy of Itolizumab in preventing cardio-renal complications in Covid-19 patients who also have acute respiratory distress. The drug has been found to reduce these complications in such patients.
According to, Chief Medical Officer, Biocon Biologics, the drug controls the hyper-activation of the immune system in response to SARS-CoV-2 virus and prevents morbidity and mortality related to the cytokine storm. The clinical trial revealed that the drug is best administered in the pulmonary phase of the Covid-19 infection when the cytokine build up is starting and the patient is experiencing shortness of breath and exhibiting abnormal chest images. It prevents progression to the hyper inflammation phase (cytokine storm) and other complications like coagulation and organ failure.
This drug has been used over 80 patients in Cuba and off-label in over 150 cases. The most important part is to know when to use the drug. This drug must be reserved for moderate to severe Covid cases with cytokine storm where oxygen requirements are rapidly going up.
The trial results revealed a statistically significant advantage over the control group of patients, in one-month mortality rate. All the patients who were administered Itolizumab were weaned off oxygen by Day 30. None among them needed ventilator support unlike the control group that did not get the drug. Some other inflammations commonly found in those patients were also suppressed, and these correlated well with clinical improvement in symptoms.
The trial comprised of 20 participants given the drug along with supportive care and 10 others given only supportive care. All 20 patients on Itolizumab recovered while three of the other 10 patients died.
Public health experts and some doctors have raised question regarding the sample size of the trial. Executive Chairperson, Biocon, responded to these questions saying that, Itolizumab has been approved in India and since the country is in a medical emergency, it was decided to go ahead with a clinical trial involving a cohort of 30 patients.
The DCGI has also exempted the drug from phase III clinical trials and allowed phase IV trials (post-marketing surveillance). Company officials have informed that they plan phase IV trials soon.
Now coming to the pricing of this drug, each injection is presented as a 25mg/5ml solution, costs Rs 7,950 per vial. Based on an average body weight of 60 kg, the therapy cost of a single dose comprising four vials is estimated at Rs 32,000 (MRP).
