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11 Jul 2020

DCGI approved Itolizumab to treat COVID-19 patients with moderate to severe acute respiratory distress 

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India’s drug regulator has approved Itolizumab, a drug used to cure skin ailment psoriasis for “restricted emergency use” to treat COVID-19 patients with moderate to severe acute respiratory distress.

Considering the unmet medical needs to treat COVID-19, Drugs Controller General of India, Dr V G Somani, approved monoclonal antibody injection Itolizumab, an already approved drug of Biocon, for restricted emergency use for the treatment of “cytokine” release syndrome in moderate to severe acute respiratory distress syndrome patients due to COVID-1.

Itolizumab is an anti-CD6 monoclonal antibody of immunoglobulin (Ig) G1 isotype that targets the SRCR1 (Scavenger Receptor Cysteine Rich) domain of CD6. The CD6 antigen is expressed primarily on T-cells, and is responsible for T cell maturation, activation and pro-inflammatory cytokine production. Itolizumab modulates CD6-mediated T cell co-stimulation, inhibits T-cell proliferation and inflammatory cytokine production.

This case study is the classic example of Drug Re-purposing. Conventionally, Itolizumab is used to treat the skin condition psoriasis and was recommended by the state’s Covid-19 task force to reduce mortality. Itolizumab is manufactured by Bengaluru-based biotech company Biocon, which has repurposed the drug for the treatment of Covid-19 patients. The drug is classified as a humanised anti-CD6 monoclonal antibody. It is a molecule produced in a laboratory. When it is incubated into the body, it acts as a substitute for antibodies that can restore or modulate the immune system’s attack on foreign bodies.

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