Bengaluru-based Biocon Limited’s drug Itolizumab, which was allowed last week for restricted emergency use to treat Covid-19, was cleared after a randomised clinical trial of only 30 patients, News18 reported on Monday.
On Saturday, the Drug Controller General of India approved the use of Itolizumab – a drug to cure skin disorder psoriasis – to treat Covid-19 patients with moderate to severe acute respiratory distress. An official had said that it was approved after its clinical trials on coronavirus patients in India was found satisfactory by an expert committee comprising pulmonologists, pharmacologists and medical experts from All India Institute of Medical Sciences for the treatment of cytokine release syndrome.
India’s drug regulator, the Central Drug Standards Control Organisation, waived the need to conduct phase 3 trials while clearing Itolizumab for Covid-19 patients, The New Indian Express reported. While experts said skipping the third phase is a bad move scientifically, Biocon’s Chief Medical Officer Sandeep Athalye claimed the phase 2 trial was “statistically significant.”
Biocon Chairperson Kiran Mazumdar Shaw said Itolizumab was approved for psoriasis in 2013 after three phases of trials. “This is a label extension and because it’s a medical emergency we were able to do a pivotal trial and received approval for restricted emergency use for particular Covid-19 patients,” she said.
Dr Hemant Thacker from Breach Candy Hospital in Mumbai said that moderate, moderate-severe, and severe Covid-19 patients form less than 4% to 5% of the patient population, according to BoomLive. “Itolizumab is not a cure to Covid-19, but it is a way to reduce mortality rates,” he said.
Biocon markets the drug under the name Alzumab and said that one full course of it would consist of four vials – each costing Rs 8,000.
After being criticised about the small sample size, the company claimed that the clinical trials met the main goals of reducing mortality and improving oxygen levels in the body. It also pointed out that all the patients who were given the drug had recovered.
Of the 30 patients, 20 were given itolizumab while the rest received standard care – antivirals, antibiotics, oxygen therapy and hydroxychloroquine. All 20 patients on itolizumab recovered while three patients who received supportive care died.
“Apart from the 20 patients who recovered in this trial, many doctors across the country decided to use Alzumab, which is available in the market, just like they use tocilizumab, to save people’s lives,” Biocon Chairperson Kiran Mazumdar-Shaw said on Monday, according to Print. “Over 150 people have been rescued by/benefitted from itolizumab or Alzumab, in Maharashtra, Gujarat, Delhi.”
At a press conference on Tuesday, Indian Council of Medical Research Director-General Balram Bhargava said scientists are trying their best to fast-track India’s two indigenous vaccine candidates for Covid-19. “It is their moral duty to develop vaccines as fast as possible as more than half a million people have succumbed to coronavirus across the world,” he added. “So fast-tracking development of vaccines is more important.”
Bhargava added that India is considered “the pharmacy of the world”. He said India or China would have to scale up the production of any vaccine candidate that is being made in other parts of the world.
Here is some of the criticism the Biocon trial has faced:
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 July 2, the Indian Council of Medical Research directed clinical trial sites of Covaxin – India’s first coronavirus vaccine candidate – 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.
As of Tuesday morning, India has reported 9,06,752 cases of the coronavirus, the third-highest in the world. The toll is now 23,727. More than 5.71 lakh people have recovered.