Even as COVID-19 patients and their families struggle to arrange for drugs such as Remdesivir and Tocilizumab, the drug regulator has approved Itolizumab (rDNA origin) for treatment of moderate to severe COVID.
Itolizumab is a monoclonal antibody which was already approved for severe chronic plaque psoriasis, an autoimmune skin disease. The drug has now been granted restricted emergency use authorisation by the Drugs Controller General of India (DCGI), based on “clinical trials” data.
“After detailed deliberation and taking into account the recommendations of the Committee [subject expert 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, and to be used in hospital set up only etc,” the health ministry said in a statement.
Since 2013, the drug is being manufactured and marketed by Bengaluru-based Biocon Limited under the brand name Alzumab, for the treatment of patients with moderate to severe chronic plaque psoriasis. It has now been repurposed for COVID-19.
According to the health ministry, Biocon has presented the Phase II clinical trial results generated in COVID-19 patients to the DCGI. The results of these trials were deliberated by the Subject Expert Committee.
“Details of primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNFα etc., were presented to have reduced significantly with the drug thereby preventing hyper- inflammation in COVID-19 patients,” the ministry said.
Doctors say COVID-19 progresses in two phases. In the first phase, the virus attacks the system and the immune system responds by driving it away. In the second phase, when the immune system goes into an overdrive — refusing to shut down — it is a phenomenon that is medically known as a cytokine storm. Drugs that are now being repurposed and experimented for COVID-19 aim to calm this storm down, and save the patient.
The average cost of treatment with the 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 Ministry of Health and Family Welfare, the health ministry statement reads. These drugs include Remdesivir and Tocilizumab, both of which are exorbitantly priced.
