DCGI approves limited use of psoriasis injection for Covid
THE HEALTH MINISTRY SAID THE DRUG IS ALSO CHEAPER THAN THE OTHER REPURPOSED MEDICINES APPROVED FOR COVID TREATMENT
NEW DELHI: The Drugs Controller General of India (DCGI) has approved restricted emergency use of Itolizumab injection for treating moderate to severe coronavirus disease (Covid-19) cases. The approval has been granted based on clinical trial data that has shown promise, officials aware of the matter said.
Itolizumab is a monoclonal antibody approved for the treatment of severe chronic plaque psoriasis. Monoclonal antibodies are lab-made proteins that act like human antibodies in the immune system and fight against foreign molecules.
The drug is manufactured and marketed by Biocon for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013. In a statement, the Union health ministry on Saturday said Biocon 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 primary endaverage point of mortality, other key endpoints of lung function such as improvement in PAO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNF etc., were presented to have reduced significantly with the drug thereby preventing hyperinflammation in Covid-19 patients.”
The emergency use authorisation involves fulfilment of certain conditions. They include taking written consent of patients and apprising them of risks and benefits of the drug and putting a risk management plan in place. The drug is to be given only in medical institutions and is not meant for sale at retail pharmacies.
The health ministry said the drug is cheaper than the other repurposed medicines approved for Covid-19 treatment. “The cost of treatment with this indigenous drug is also lesser than comparable drugs that are part of the ‘investigational therapies’ indicated in the clinical management protocol for Covid-19,” it said.
The drugs approved for use in treatment in India include antivirals like remdesivir, and immunosuppressant tocilizumab, steroid dexamethasone, and anti-malarial hyrdoxychloroquine.
“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 has repurposed Itolizumab… for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to Covid-19,” said Biocon Ltd. in a statement.
“Lok Nayak Hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab…,” said Dr Suresh Kumar, medical director, Lok Nayak Hospital, in a statement.