CONTROVERSY: DCGI exempts Biocon from Phase 3 trial of COVID drug Itolizumab, ICMR sees red
Bengaluru: In a major controversy, the exemption of biotechnology major Biocon from conducting Phase 3 trials of its psoriasis drug Itolizumab, for its use in moderate to severe COVID-19 patients has raised many eyebrows.
On July 10, the Drugs Controller General of India (DCGI) approved the biologic drug under emergency use in India for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 in India. The drug's approval is based on the results of phase 2 clinical trials involving 30 patients at four hospitals in New Delhi and Mumbai.
The Itolizumab trial was a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive Itolizumab plus supportive care, while 10 patients in the control group received supportive care alone. The primary endpoint was mortality at one month.
Thereafter, the company announced the breakthrough drug and tweeted;
#ProudToShare: #Biocon's Breakthrough Drug #Itolizumab Receives DCGI Nod for its Use in Moderate to Severe #COVID19 Patients, the first novel biologic therapy to be approved by DCGI for treating patients with moderate to severe COVID-19 complications. https://t.co/rrgf9ej2XH pic.twitter.com/ADXXWRZO2X— Biocon (@Bioconlimited) July 11, 2020
The company further announced the launch of the drug on July 13, at a price of around 8,000 per vial - the entire cost of the therapy would be around Rs 32,000.
However, what triggered a debate questioning the accuracy of the trial is the small sample size and the parameters of the DGCI when it comes to approving new drugs for coronavirus treatments. As per various media accounts, in addition to clearing the drug despite the small number of patients in the trial, DGCI also approved it without the trial going through Phase 3, which has caused concerns from observers.
Critics wonder if the trial is underpowered due to the small sample size to pick a real effect of reducing mortality. The waiving off Phase 3 trial and allowing the company to conduct post-marketing surveillance, also called Phase 4 has been severely condemned as;
Is there enough data to support this? Is it ethical to publicise this experimental use like this? https://t.co/HzSj2XSb2e— Mukul Bagga (@Indianmarketeer) July 12, 2020
According to media reports, the details provided by the company failed to convince independent scientists about its effectiveness.
However, Biocon's Chief Kiran Mazumdar Shaw in defense of the same told IANS that if they did a 100-patient trial on Itolizumab, it would have taken three months, even as patients were dying from COVID-19, adding that the process followed has been extremely robust, reports money control.
"Until the vaccine comes, we certainly need life-saving drugs. I think what we are doing across the world is to see how we can either repurpose drugs or develop new drugs to treat this pandemic," Biocon Executive Chairperson Kiran Mazumdar-Shaw as quoted in a virtual press conference.
Speaking on the efficacy of the Itolizumab drug, Shaw stated that pivotal data showed reduction 'but might need Phase IV trials to support the result.'
However, Shaw's justification did not seem to go down well and though the Indian Council of Medical Research (ICMR) allowed the emergency use of the two drugs Itolizumab and Tocilizumab to treat COVID-19 patients, the Director-General of the medical body, Balram Bhargava, has acknowledged that there is no evidence from clinical trials of the two drugs that it reduces death among severely ill COVID-19 patients, reports The Hindu.