DGCI okays Itolizumab drug for restricted emergency use on COVID patients

DGCI okays Itolizumab drug for restricted emergency use on COVID patients

The Drug Controller General of India (DCGI) granted permission for the "restricted emergency" use of Itolizumab injection on moderate to severe COVID-19 patients amid the rising number of cases across India.

Itolizumab is now approved for the treatment of CRS in patients with moderate to severe ARDS due to COVID-19.

An EUA is usually given by a regulator if there is an urgent need for a treatment regime against a particular indication, and interim data from drug trial shows that it is safe and somewhat effective in treating that particular disease or its symptoms.

Noting that this positions India amongst the leading global innovators in their effort to overcome the COVID-19 pandemic, she said, the randomized control trial indicated that all the patients treated with Itolizumab (ALZUMAb) responded positively and recovered.

The drug was launched in 2013 as a monoclonal antibody by Indian pharmaceutical company, Biocon. The anti-psoriasis drug underwent a clinical trial at four hospital sites, and its phase-II results were considered by the DCGI before the nod.

"Details of primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented".

India's drug regulator has authorised Itolizumab, a drug used to remedy pores and skin ailment psoriasis for "restricted emergency use" to deal with COVID-19 sufferers with reasonable to extreme acute respiratory misery, officers informed PTI on Friday.

He also informed that written informed consent of each patient is required before the use of this drug. The immune system is hyperactive and uncontrolled in Covid-19; it produces excess cytokines, T-cells and antibodies.

It said Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications.

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