The National Task Force on COVID-19 has decided against including Itolizumab drug in clinical management protocols for treating the disease.
Biocon’s Itolizumab is an approved drug which is used for treating psoriasis, a skin condition. Recently, Drugs Controller General of India (DCGI) approved Itolizumab restricted use in infected Covid patents.
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.
As per the reports, a majority of the members of the task force were against its inclusion in clinical management protocols for treating covid-19.
“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,” unidentified officials from the task force told The New Indian Express.
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.
A Biocon spokesperson told Scroll.in that the company would provide more evidence to the National Covid Task Force to enable the committee to reconsider its decision. “Nearly 1,000 patients have used the drug across the country with good outcome data,” the spokesperson said.
Itolizumab “has proven to be an efficacious intervention in treating the serious hyper-immune response seen with COVID-19,” said Kiran Mazumdar-Shaw, executive chairperson of Biocon, in a company statement, soon aftr the drug was approved by the Drugs Controller General of India for the emergency treatment of acute respiratory distress syndrome (ARDS) in patients with coronavirus disease 2019 (COVID-19). Mazumdar-Shaw said the results came from a randomized controlled study of Itolizumab that focused on safety and efficacy in preventing CRS in patients with ARDS due to COVID-19.
Biocon said in a statement that itolizumab (Alzumab), long used for treatment of acute psoriasis, was approved in injectable form, 25 mg/5 mL, for use in India for the treatment of cytokine release syndrome in patients with moderate-to-severe ARDS. The repurposed drug was originally launched in India in 2013 for treating chronic plaque psoriasis.