The COVID-19 task force, at a meeting on Friday, recommended against the emergency use of psoriasis drug, itolizumab, according to a person privy to proceedings.
Task force recommendations usually reflect in periodic guidelines issued by the Indian Council of Medical Research on what drugs, therapies may be used under what conditions for COVID-19 patients.
Because the ICMR is yet to issue fresh guidelines on itolizumab, the drug can still be used by physicians as it still has been approved this month for emergency use by the drug regulator.
“The available evidence on efficacy was deemed inadequate and there were concerns over generalised immunosuppression,” the person told The Hindu. “Guidelines are updated whenever a new drug is introduced or an old one is deleted. The All India Institute of Medical Sciences is in charge of preparing them.”
The Hindu Explains | Why is a psoriasis drug being used to treat COVID-19 patients?
Rajesh Bhushan, task force member and Officer on Special Duty, Health Ministry, told The Hindu that post the group’s discussion, “more information was desired” from clinicians on the way the drug addresses the ‘cytokine storm.’ “Based on this information, the task force would engage with the subject in the next meeting.”
Antibody drug
Itolizumab is a lab-cloned antibody drug approved for psoriasis, developed by Bengaluru-based Biocon Biologics.
It has been approved for emergency use in the treatment of moderate and severe disease by the DCGI, in patients who manifest acute respiratory disease.
This acute form of the disease frequently occurs due to a pro-inflammatory cytokine storm, or a rush of messenger chemicals in the body that stimulate a variety of virus-destroying cells that also end up harming healthy tissue and organs as collateral damage.
Critics have earlier pointed out that drug’s evidence for preventing deaths in COVID-19 patients rests on an inadequately performed trial.
This month, Balram Bhargava, Director-General, ICMR, also said that there was yet no evidence from trials that itolizumab and tocilizumab reduce death in severely ill COVID patients.
A Biocon spokesperson told The Hindu on Sunday that more evidence would be provided to the task force and plans for a 200-patient ‘phase-4 trial’ across 10-15 hospitals was on the anvil. “The results from the phase-4 will create a larger body of evidence for the efficacy of itolizumab. Nearly 1,000 patients have used the drug across the country with good outcomes.”