Written by Anuradha Mascarenhas | Pune | Updated: July 21, 2020 7:33:30 am 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. (Express Photo/Praveen Khanna)

A repurposed drug, Itolizumab, is one of the newest treatments for Covid-19 approved in India. The Drug Controller General of India recently approved it as a novel biologic therapy for restricted emergency use. The decision has also sparked controversy because of the small size of the clinical trials, and because exemption has been granted from phase-III trials.

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. The drug, developed by Bengaluru-based Biocon, was approved in 2013. It is considered safe and effective for the treatment of psoriasis.

Why was it approved for emergency use in Covid treatment?

The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs, and, in the worst scenario, 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.

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Basically, 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 showed 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 hyperinflammation phase (cytokine storm) and other complications like coagulation and organ failure, according to Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics.

The drug has been used over 80 patients in Cuba and off-label in over 150 cases. According to Dr Shashank Joshi, Dean, Indian College of Physicians, the most critical part is to know when to use the drug and it must be reserved for moderate to severe Covid cases with cytokine storm where oxygen requirements are rapidly going up. usually between the 8th day onwards of Covid infection.

What were the results of the trial?

The trial results showed 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, and none needed ventilator support unlike the control group that did not get the drug. Some other inflammations commonly found in such patients were also suppressed, and these correlated well with clinical improvement in symptoms. Overall, the drug was found well-tolerated.

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How large was the trial?

The trial had 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 used social media to question the sample size of the trial. When journalists raised this question at a virtual press conference, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said 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. She said the regulatory process was extremely robust and the scientific discussions on the trial was of a very high order.

The DCGI has also exempted the drug from phase III clinical trials and allowed phase IV trials (post-marketing surveillance). Itolizumab is not a new drug and was approved in India since 2013. We had done phase II and III trials, and got the approval. In the past seven years, its been used in psoriasis and we know how the mechanism works Biocon Biologics CMO Dr Athalye said. Company officials said they plan phase IV trials soon.

How much does it cost?

Each injection is presented as a 25mg/5ml solution, which 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).

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Explained: What is Itolizumab, newly cleared for Covid-19? - The Indian Express