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Itolizumab, a drug used in severe skin conditions like Psoriasis, has now been granted restricted emergency use authorisation by the Drugs Controller General of India (DCGI) for use in Covid-19 treatment.
Ministry of Health and Family Welfare in a statement said: “After detailed deliberation and taking into account the recommendations of the Committee, DCGI has decided to grant permission to market the drug under Restricted Emergency Use of the drug for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients due to Covid-19, subject to some conditions like informed consent of patients, a risk management plan, to be used in hospital set up only.”
CRS is a hyper-reaction of a body's immune system leading to severe deterioration in Covid-19 patients.
Itolizumab is a monoclonal antibody, which was already approved for severe chronic plaque psoriasis. DCGI has stated that the nod is based on clinical trials data.
Indian pharma major Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under the brand name Alzumab. “This indigenous drug has now been repurposed for Covid-19,” Biocon has presented the Phase II clinical trial results generated in Covid-19 patients to DCGI.
“The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office. Details of the primary endpoint of mortality, other key endpoints of lung function such as improvement in partial pressure of oxygen and oxygen saturation were presented. Key inflammatory markers Interleukin 6 and Tumour Necrosis Factor alpha were presented to have reduced significantly with the drug thereby preventing hyper-inflammation in Covid-19 patients,” the MoHFW statement said. Inflammatory markers complicate Covid-19 patient's condition and lead to it’s deterioration.
The average cost of treatment with this indigenous drug Itolizumab is also lesser than comparable drugs which are part of the “Investigational Therapies” indicated in the Clinical Management Protocol for Covid-19 of the MoHFW, the statement says.
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