New Crown Outbreak: 12.87 million! The world's first COVID-19 biological drug: Baikang immunomodulation CD6 antibody LZUMAb (Itolizumab) India approved!

July 12, 2020 // At present, the outbreak of new crown pneumonia is still spreading rapidly around the worldAccording to Baidu's "Real-Time Big Data Report on the Outbreak of New Coronavirus Pneumonia", as of 19:00 on July 12, 2020, more than 12.87 million cases had been confirmed worldwide and more than 568,000 deaths had been reported, India's largest biopharmaceutical company, Bicon, recently announced that the General Administration of Medicines (DCGI) has approved Itolizumab (25mg/5mL, ALZUMAb ®, intravenous preparations) for patients with moderate to severe acute respiratory distress syndrome (ARDS) caused by the new coronavirus pneumonia (COVID-19) for the treatment of cytokine release syndrome (CRS)Itolizumab, a new immunomodulatory anti-CD6 IgG1 monoclonal antibody, was approved in India in 2013 and is the world's first anti-CD6 monotonica, sold under the brand name ALZUMAb, for the treatment of patients with chronic plaque type psoriasisnote, Itolizumab is the world's first approved new biologic agent for the treatment of moderate to severe COVID-19 complications, from Baikang application for clinical trials in patients with COVID-19 to final commercial approval, in just about 120 daysprice, the highest retail price (MRP) for Itolizumab is 7,950 rupees ($745) per vial, which usually requires four bottles for COVID-19 patientsoverall, the drug could cost up to 32,000 rupees (about 2,980 yuan)Itolizumab is also the third drug approved in India to treat COVID-19in late June, two Redsivir generics, FabiFlu, were approved in India for the treatment of severe COVID-19 patients, India has confirmed more than 853,000 cases, 293,000 existing cases, cured 537,000 cases and more than 22,000 deathsnew coronavirus (SARS-CoV-2) induces the immune system to overreact, producing a large number of cytokines that can cause serious damage to the lungs and other organs, at worst, multiple organ failure or even deathpsoriasis is a debilitating skin diseaselink between psoriasis and COVID-19, Itolizumab reduces the aggressive and self-destructive response of the body's immune systemin patients with COVID-19, as the virus proliferates and develops in the body, the body's immune system begins to overreact, in medical terms, cytokine storm, which is the leading cause of death in patients with COVID-19Itolizumab's unique immune-regulating mechanisms include binding to CD6 receptors and blocking the activation of T lymphocytes, which in turn inhibits inflammatory cytokines, thereby reducing cytokine storms and deadly inflammatory responsesDCGI's approval of ITolizumab for THE treatment of COVID-19 patients, based on the successful conclusions of a randomized controlled clinical trial conducted at several hospitals in Mumbai and New Delhithe study focused on the safety and effectiveness of CRS in patients with moderate-to-severe ARDS prevention caused by COVID-19 study, one group received standard care and the other received standard care plus Itolizumab results show that the study reached the primary endpoint of reduced mortality, as well as other key secondary endpoints of efficacy and biomarkers patients treated with standard care and Itolizumab showed a positive treatment response and were all discharged from the hospital in fact, the day after Itolizumab was administered, the patient's oxygen support levels began to decline, and most patients recovered within 2 weeks of discharge control group receiving standard care, patient sewage shone in one-month mortality, the Itolizumab group was significantly better than the control group also significantly better than the control group in terms of improvements in key efficacy parameters PaO2 and SpO2 (blood oxygen saturation) by the 30th day, all patients in the Itolizumab group stopped oxygen supplementation, while most patients in the control group needed ventilator support the critical secondary endpoints of clinical inflammatory markers (e.g IL-6, TNF-alpha, serum ferritin, d-dipolymer, lactic acid dehydrogenase (LDH), hypersensitivity C reaction protein (CRP), Itolizumab showed significant clinical inhibition after administration and was well associated with clinical symptom improvement and chest X-ray images studies, Itolizumab had good overall tolerance and safety these results confirmed that Itolizumab treated patients with moderate and severe ARDS caused by COVID-19, which prevented morbidity and mortality from cytokine storms all the doctors who have used Itolizumab are very satisfied with the results note, after the announcement of the Itolizumab clinical results and before DCGI approved the treatment of COVID-19, many people have started using Itolizumab for COVID-19 outside the label, and more than 100 patients are said to have benefited from the off-label drug () Original source: Coronavirus drug: Biocon's Itolizumab approved by DCGI; full course for Rs 32,000.