DCGI approves Itolizumab for restricted emergency use in COVID-19 treatment

DCGI approves Itolizumab for restricted emergency use in COVID-19 treatment

DCGI approves Itolizumab for restricted emergency use in COVID-19 treatment

In 2013, Biocon had launched Itolizumab, an anti-CD6 IgG1 monoclonal antibody biologic therapy for treating chronic plaque psoriasis, which it has now repurposed for treating COVID-19 patients.

A committee comprising of various medical experts from All India Institute of Medical Sciences (AIIMS) were of the view that Itolizumab was found to be satisfactory for treatment of cytokine release syndrome in COVID-19 patients.

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.

India's drug regulator has approved Itolizumab, a medicine used to cure psoriasis for "restricted emergency use" to treat COVID-19 patients with moderate to severe acute respiratory distress, informed officials.

So far, itolizumab has been used off-label for more than 100 Covid-19 patients in India. The results of these trials were deliberated by the Subject Expert Committee.

Biotechnology major Biocon on Saturday announced that its 'breakthrough drug, ' Itolizumab has received Drugs Controller General of India's (DCGI) approval for its use in moderate to severe COVID-19 patients. The immune system is hyperactive and uncontrolled in Covid-19; it produces excess cytokines, T-cells and antibodies.

The approval of the drug as a form of restricted emergency treatment for COVID-19 patients comes at a time when the number of coronavirus cases in the country is increasing at an alarming rate.

"We believe the unique mechanism of action could help prevent and treat CRS or cytokine storm, seen as a complication of covid-19 that is responsible for the morbidity and mortality in these patients". These drugs include Remdesivir and Tocilizumab, both of which are exorbitantly priced.

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