NEW DELHI: The National Task Force on COVID-19 has decided not to recommend the drug itolizumab in the national protocol for treating the infection for now despite the drug regulator's decision to authorize its emergency use in patients recently.
In its meeting on Friday, most members of the task force felt that the evidence cited in favour of the medicine is "inconclusive".
The task force under Niti Aayog member (health) Dr V K Paul is the apex body to advise the government on policies and technical aspects related to the management of the outbreak.
“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,” sources in the task force told The New Indian Express.
The EUA granted by the Central Drugs Standards Control Organisation (CDSCO) to this drug, originally developed for auto-immune skin disease psoriasis, for moderate to severe COVID-19 cases earlier this month had sparked a controversy as the approval was based on a very small phase 2 trial with just 30 patients.
Later, it also emerged that the drug regulator had waived the manufacturer from doing a phase 3 trial considered crucial for generating scientific evidence for a therapeutic intervention as they include a large number of subjects and allowed it to move to phase 4 trial directly which includes post-marketing surveillance.
The CDSCO, however, in a press statement had said that its subject expert committee had issued the permission after findings of the trial were found “satisfactory.”
The injectable monoclonal antibody medicine, which was launched in 2013 under the brand name Alzumab, works by reducing severe inflammatory response in the body.
In a press conference, Biocon executive chairperson Kiran Mazumdar Shaw, had claimed that the results of the trial were “compelling” and “could save lives”. The drug costs around Rs 8,000 per vial and a full course for COVID-19 patients costs about Rs 32,000.
Similar approval granted to the Indian version of favipiravir by Glenmark to treat mild to moderate COVID-19 cases by the CDSCO had also failed to impress the task force last month.
Meanwhile, yet another issue discussed in the task force meeting included a repeat nationwide sero-surveillance to check for exposure to the COVID-19 virus.
“An expert group on epidemiology made the presentation on the proposed study design but we have suggested some changes and it will be discussed in the next meeting before the survey hits the ground,” said a task force member.