Health ministry decides against including Itolizumab in clinical management protocols for COVID-19

The permission to market the drug was granted for the treatment of cytokine release syndrome in 'moderate' to 'severe' Acute Respiratory Distress Syndrome patients due to COVID-19.

The National Task Force on COVID-19 has decided against including Itolizumab drug in clinical management protocols for treating the disease even though the DCGI has approved its "restricted emergency use" in infected patients, official sources said.

Considering the unmet medical needs in COVID-19, Itolizumab, an already approved drug of Biocon, used for treating psoriasis -- a skin condition -- was approved for "restricted emergency use" in the treatment of coronavirus by the Drugs Controller General of India (DCGI) recently.

The permission to market the drug was granted for the treatment of cytokine release syndrome in 'moderate' to 'severe' Acute Respiratory Distress Syndrome patients due to COVID-19.


"The issue of including the drug in the clinical protocols was discussed in a meeting held on Friday. A majority of the members of the task force opined that there was not enough evidence currently to get the drug included in the clinical management protocols for COVID-19," said an official source.

A domestic biopharmaceutical company, Biocon, has been manufacturing and marketing Itolizumab, a monoclonal antibody, for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013, under the brand name ALZUMAb, the Union health ministry had earlier said.

However, a Biocon spokesperson said, "The National Covid Task Force needs to see more evidence and we will provide them large real-world data to enable the committee to reconsider its decision on inclusion of Itolizumab in the protocol."
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"Nearly 1,000 patients have used the drug across the country with good outcome data," the company spokesperson said.
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