BENGALURU: Doctors who conducted initial trials of the repurposed drug, Itolizumab — manufactured by Bengaluru-based Biocon, to treat COVID-19 patients say that the trials were successful and the drug can be used for emergencies. But the approval by the Drugs Controller General of India to market the drug has brought about mixed reactions and some experts believe that the study on which the approval is based has shortcomings.
Dr Hemant Thacker of Mumbai’s Breach Candy Hospital, one of the first doctors to carry out the clinical trials, told TNSE, “During the trials, I saw success with 21 patients and another nine admitted to the ICU. At a time when the world is grappling with no cure and there are medicines showing results, we should appreciate them.” He said the drug acted well on moderately-severe and severely-ill patients. Many patients with initial oxygen saturation levels of less than 80 per cent, who normally would need ventilator support with little chance of survival, recovered when treated with Itolizumab.
Questioning the sample size of the trials, Dr Arvinder Soin, researcher and chairman, Medanta Liver Institute, said, “The study results are not peer-reviewed by external validators and experts yet. There is scanty evidence to allow use of the drug. It is just another in the growing list of drugs for off-label emergency use, but with no proven efficacy for routine use.
What we need is a safe drug that would work for most if not all patients, and for that, proving efficacy and safety in a phase-3 randomised controlled trial with a larger sample size is the gold standard.” Itolizumab, approved in 2013, is used to treat psoriasis and is considered safe. Dr Vishal Rao, head and neck oncologist at HCG, who is also working on cytokine therapy to cure mild and moderate patients, said, “Phase-3 clinical studies are important to establish the drug’s efficacy, even if there is enough data and being an old drug being repurposed for COVID-19.
To make it global, it’s important to convince regulatory authorities about its safety.” Biocon Chief Kiran Majumdar-Shaw said, “The company will conduct a larger trial or phase-IV soon. DGCI has clearly stated that we have got a restricted emergency use approval for this drug and must conduct a larger phase IV trial.” She had earlier said the data will be published in journals. “Over 150 patients have benefitted from this off-label. They may not have been on a clinical trial but all of them have recovered,” she added.
According to bio-ethics researcher Anant Bhan, “The Bicon Itolizumab trial as described is a small clinical trial with only 30 patients which has as of yet not been published to my knowledge. The exemption of phase 3 studies also raises a lot of concerns as such studies help us understand efficacy.”