GUWAHATI: Assam has procured the Itolizumab drug which is used for the treatment of patients with moderate to severe psoriasis, to treat COVID-19 patients.
The drug has been approved by the Central Drugs Standard Control Organization (CDSCO) for the treatment of patients infected by the novel coronavirus disease.
The national drug control body approved Tocilizumab and Itolizumab for treatment, both of which are costly and not easy to procure. Assam is the first state to have acquired Itolizumab just 3 days after the approval, according to the state health ministry.
"The national drugs control body has approved two new drugs - Tocilizumab and Itolizumab but they are costly and not easily available. Assam is the first state to first acquire Itolizumab just three days after CDSCO approved its use," said Himanta Biswa Sarma in a press conference on July 16.
"Assam has already been using Dexamethasone, also for easing symptoms, and antiviral drug Remdesivir, which have also been approved by CDSCO for COVID-19 treatment," said the minister, listing the drugs currently being used for treating patients infected by the virus.
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Suppliers of the drug have only been able to provide 100 vials of Itolizumab, each of which costs Rs. 10,000. It is estimated that a person would come out healthy after being treated by Rs 40,000 worth of these drugs.
Hospitals have reportedly begun with aggressive treatment of COVID-19 patients before they slip into a critical stage when it gets difficult to treat the patient.
What is the controversy around Itolizumab?
Biocon Limited, a Bangalore based pharmaceutical company which produces Itolizumab, the drug which was approved to treat COVID-19 on July 11 by the Drug Controller General of India (DCGI) for restricted emergency use for treating moderate to severe coronavirus patients, is not a newly introduced drug and has been there from a long time. It was approved in 2013 for treating psoriasis.
Director-General of the Indian Council of Medical Research (ICMR), Balram Bhargava, said that there is not enough evidence from clinical trials that the drugs Itolizumab and Tocilizumab reduce mortality in COVID-19 patients.
Further, critics are pointing towards the following issues with the same:
• The small size sample of the clinical trial,
• Exemption of Phase-3 trial,
• Use of the drug as off-label for COVID-19, and
• Making claims to the press before the data being published in a peer-reviewed journal.
Results of Trial
The approval was based on favorable data received from a controlled, randomized clinical trial on just 30 patients which were conducted in the hospitals located in New Delhi and Mumbai. The trials were carried out in:
• All India Institute of Medical Services
• Lok Nayak Jai Prakash Narayan Hospital
• BYL Nair Hospital
• King Edward Memorial (KEM) Hospital
20 out of 30 patients, who were treated with Itolizumab, portrayed significant improvement in their condition and no mortality was witnessed.
On the other hand, the rest of the 10 patients were treated with compromised antivirals, standard care with hydroxychloroquine, and oxygen therapy. In this trial, 7 patients survived and 3 died.
But critics wonder if the trial is underpowered due to the small sample size to pick a real effect of reducing the mortality.
Absence of a Phase-3 Trial
Phase-3 is a large, multi-centre trial where the drug is tested on patients to demonstrate efficacy on treating the intended disease compared to placebo or regular standard of treatment.
The DCGI has waived Biocon’s need to conduct phase 3 clinical trials and allowed the company to conduct post-marketing surveillance, also called Phase 4. But some experts say that given the complex nature of the COVID-19 disease, Phase-3 ought to have been done.
Hurried Announcements
The way the company went to the media before publishing the data in a reputed journal that would have allowed independent experts to review the same, is also being widely criticized.
(With Inputs from National Media)
