NEW DELHI: The drug regulator, the Central Drug Standards Control Organisation, waived the necessity to conduct phase 3 trial when it cleared the use of Itolizumab, a medicine manufactured by biotechnology firm Biocon, for Covid-19 patients.
The injectable monoclonal antibody medicine, that was launched in 2013 under the brand name Alzumab, has been recommended for moderate to severe Covid 19 cases under certain conditions.
An expert committee of the CDSCO said in a statement on July 10 that the permission was issued after findings of the trial were found “satisfactory.” Calls and messages to Drug Controller General of India V G Somani on the issue remained unanswered. Dr Sandeep Athalye, chief medical officer of Biocon, insisted that the phase 2 trial was “statistically significant.”
“Apart from the trial sites, 15-20 doctors in nursing homes have been using the drug and are very happy with the results,” he said. “There is therefore no need to do a phase 3 trial and we will submit data from phase 4 trial,” he said.The company announced that the phase 2 trial had 30 patients.
Kiran Mazumdar Shaw, executive chairperson of Biocon, said the results of the trial were “compelling” and “could save lives.” But many experts said Phase 3 trials are the bedrock of scientific evidence for a therapeutic intervention as they include a large number of subjects. “So far, there is scanty evidence to allow the use of Itolizumab for Covid 19,” said Dr Arvinder Soin, a researcher and senior doctor with Medanta hospital in Gurugram.
S Srinivasan of the All India Drug Action Network said the “CDSCO may be well within law to allow the company to skip phase 3 trials using its emergency powers, it’s a bad move scientifically.”