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These procedures can be very useful in relieving the pain and can be performed by an experienced pain management physician, usually under x-ray or ultrasound guidance.
Researchers around the world are trying all possible means to find a solution to the COVID-19 pandemic. In clinical trials, some medications used for the treatment of other ailments have also shown promising results for the treatment of coronavirus patients. Itolizumab, a drug used to cure skin ailment psoriasis, is one such medication. Based on promising clinical trial data, the Drugs Controller General of India (DCGI) has approved restricted emergency use of Itolizumab injection for treating COVID-19 patients with moderate to severe acute respiratory distress.
The drug, manufactured and marketed by Biocon, has been in use since 2013 under the brand name of Alzumab for the treatment of severe chronic plaque psoriasis. The company presented the phase II clinical trial results generated in coronavirus patients to DCGI. After the results were found satisfactory by the subject expert committee, the DCGI granted permission to market the drug under restricted emergency use for the treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome patients due to COVID-19, the Union health ministry said in a statement on Saturday.
Itolizumab is a monoclonal antibody injection approved for the treatment of psoriasis - a skin disorder that causes skin cells to multiply up to 10 times faster than normal. It is made from lab-made proteins that act like human antibodies in the immune system to fight against foreign molecules. Biocon conducted trails to see Itolizumab's effect on Covid-19 patients. The results of the trials showed improvement in PaO2 and O2 saturation related to lung function. The drug also significantly reduced key inflammatory markers IL-6, TNF , etc., thereby preventing hyper-inflammation in COVID-19 patients.
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Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, Biocon Ltd. in a statement. The company added that it has repurposed Itolizumab for the treatment of cytokine release syndrome in moderate to severe ARDS patients due to COVID-19.
The DCGI's approval of Itolizumab is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi, the company noted.
Itolizumab was used to treat eight COVID-19 patients, who had an oxygen saturation of less than 80%, in Lok Nayak Hospital. In a statement, Dr Suresh Kumar, medical director, Lok Nayak Hospital, said that the patients did extremely well even with a single dose of Itolizumab. They recovered completely after treatment with Itolizumab and got discharged, he added.
The emergency use authorization requires the fulfillment of certain conditions such as:
According to the Health Ministry, the average cost of treatment with this indigenous drug is lesser than other repurposed medicines approved for the treatment of Covid-19. So far four drugs have been approved for use in Covid-19 treatment in India as investigational therapies. These include remdesivir, tocilizumab, steroid dexamethasone, and anti-malarial hyrdoxychloroquine.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon's biomanufacturing facility at Biocon Park, Bengaluru.