Itolizumab (rDNA origin), a monoclonal antibody which was already approved for severe chronic plaque psoriasis, has now been granted Restricted Emergency Use authorisation for COVID 19 patients by the Drugs Controller General of India (DCGI) based on clinical trials data.
What is Itolizumab?
- Itolizumab (rDNA origin) is a monoclonal antibody that is already an approved drug of Biocon for severe chronic plaque psoriasis.
- Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in Covid-19 patients.
- Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under brand name Alzumab.
The average cost of treatment with Itolizumab is less than comparable drugs which are part of the “Investigational Therapies” indicated in the Clinical Management Protocol for COVID-19 of the MoHFW.
- Itolizumab appears to have beentested on too few patients to reliably conclude on its benefits and with such a small sample size it would be unwise to claim it as the final and fully successful drug.
- 30 patients were recruited across four hospitals and 20 of them were given Itolizumab along with the ‘standard of care treatment’ and 10 were given only standard of care.
- Nobody died from the set of 20 patients and 3 patients died from the set of 10 patients.
- DCGI under gamut of Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licensesof specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.
- DCGI lays down standards and quality of manufacturing, selling, import and distribution of drugs in India.
- It acts as appellate authority in case of any dispute regarding quality of drugs.
- It prepares and maintains national reference standard.
- It brings about uniformity in enforcement of Drugs and Cosmetics Act.
- It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.