The National Task Force on the coronavirus pandemic has decided not to recommend the drug itolizumab in the national protocol for treating the Covid-19 infection for now, The New Indian Express reported on Sunday. The drug was struck down as a treatment option at a meeting on Friday, as most members of the task force felt the evidence cited in favour of the medicine is “inconclusive”.
Itolizumab, developed by Bengaluru-based Biocon Limited, was approved by the Drug Controller General of India earlier this month, to treat patients with moderate to severe acute respiratory distress. It was cleared after a randomised clinical trial of only 30 patients. The move was widely criticised by health experts who said that 30 is a very small number of participants for a phase 2 clinical trial – too small to lend itself to a statistically significant outcome. Later, it also emerged that the Central Drug Standards Control Organisation had waived the need to conduct phase 3 trials while clearing Itolizumab for Covid-19 patients.
“There was a long discussion on itolizumab but most members felt that there is no substantial evidence yet to include it in the national Covid-19 clinical management guidelines,” unidentified officials from the task force told The New Indian Express. The task force, which is headed by Niti Aayog member (health) Dr VK Paul, is the principle body to advise the government on policies and technical aspects related to the management of the pandemic.
A Biocon spokesperson told Scroll.in that the company would provide more evidence to the National Covid Task Force to enable the committee to reconsider its decision. “Nearly 1,000 patients have used the drug across the country with good outcome data,” the spokesperson said. “Also, we have already announced that we have planned for a 200 patient pan-India phase 4 trial to be conducted across 10-15 hospitals. The study protocol has been submitted to the DCGI and we will commence the trial soon.”
The injectable monoclonal antibody medicine, which was launched in 2013 under the brand name of Alzumab, works by reducing severe inflammatory response in the body. The drug costs around Rs 8,000 per vial and a full course for Covid-19 patients would cost about Rs 32,000.
After being criticised about the small sample size, Biocon had claimed that the clinical trials met the main goals of reducing mortality and improving oxygen levels in the body. It also claimed that all the patients who were given the drug had recovered. Biocon’s chairperson Kiran Mazumdar Shaw had claimed that the results of the trial were compelling and “could save lives”.
There is no cure for the coronavirus, and treatment is symptomatic, though the recovery rate both in India and globally is high. On June 13, the Ministry of Health and Family Welfare approved the use of the drug remdesivir for “restricted emergency use” in moderate cases.
Countries across the world are also racing to develop a vaccine for the coronavirus. On Friday, theAll India Institute of Medical Sciences in New Delhi began human trials of Covaxin – India’s first coronavirus vaccine candidate. A shot of the Covaxin vaccine was given to a healthy 30-year-old male.
On July 2, the Indian Council of Medical Research had directed clinical trial sites of Covaxin to fast-track approvals and said that it planned to launch the vaccine for public use by August 15. However, the directive was heavily criticised for setting an unreasonable deadline.
India’s second vaccine candidate – Gujarat-based pharmaceutical giant Zydus Cadila’s ZyCoV – also entered the human trials stage earlier this month. The clinical trials of ZyCoV will be conducted across multiple sites in India with over 1,000 subjects.
Researchers working on both vaccines will need at least three months to get a reliable set of data.