Itolizumab is the latest drug to be approved by Drug Controller General of India (DCGI) for “restricted emergency use” to treat Covid-19 patients. 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.
The drug was launched in 2013 as a monoclonal antibody by Indian pharmaceutical company, Biocon. In US, Australia, Canada, and New Zealand, biotechnology company Equillium has rights to develop and sell the drug. Itolizumab is used for skin disorder psoriasis, rheumatoid arthritis, multiple sclerosis, and autoimmune disorders.
The drug was repurposed for Covid-19 this year, first used to treat patients in Cuba to reduce inflammation in lungs. In India, it is sold under the brand name Alzumab.
“After detailed deliberation and taking into account recommendations of the committee, DCGI has decided to grant permission to market the drug under Restricted Emergency Use for the treatment of cytokine release syndrome (CRS) in patients suffering from moderate to severe acute respiratory distress syndrome (ARDS) due to Covid-19, subject to some conditions like informed consent of patients, risk management plan, to be used in hospital set-up only, etc,” a statement from the Ministry of Health and Family Welfare read.
The approval may also bring down the cost of treatment for Covid-19 patients suffering from CRS, as per the health ministry.
So far, itolizumab has been used off-label for more than 100 Covid-19 patients in India. The market price for 100 mg dosage of intravenous injection will be Rs 30,000. It is manufactured at the Bengaluru-based Biocon Park facility.
The phase-II results of itolizumab showed improvement in lung function, oxygen saturation levels, oxygen pressure in arterial blood, and reduction in inflammation. “The drug can be used as soon as a cytokine storm begins or at the height of cytokine storm. The immune system is hyperactive and uncontrolled in Covid-19; it produces excess cytokines, T-cells and antibodies. Instead of killing the virus, it kills humans. This drug starts modulating the immune system,” Kiran Mazumdar Shaw, executive chairperson, Biocon, told The Sunday Express.
Inputs from ENS Economic Bureau
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