Nation’s drug controller general of India (DCGI) has endorsed Itolizumab, for “restricted emergency use” to treat COVID-19 patients with acute to severe respiratory distress syndrome on Friday.
Considering the neglected clinical needs to treat COVID-19, Drugs Controller General of India, Dr V G Somani, has grant usage of Biocon’s recombinant anti-CD6 monoclonal antibody infusion Itolizumab in moderate to extreme intense respiratory discomfort in COVID-19 patients. Itolizumab was earlier prescribed for many years to treat chronic plaque psoriasis, but has been repurposed for treating respiratory distress in covid-19 patients.
One of the official stated that after observing preliminary trial results in Covid-19 patients in India, subject expert committee consisting of pulmonologist, pharmacologist, medicine experts from AIIMS etc. have decided to restrict for emergency purpose with certain conditions.
As per the reports, doctors have to get the informed consent form filled by the patient in a well defined manner prior to prescribing the drug. Additionally, Biocon Ltd that manufactures the drug has to check every patient’s case to assess the safety and efficacy of the drug to the one, who is being administered as part of the the post-marketing trial to check likely adverse reactions.
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