There is no possibility of coronavirus stopping in the country. Compared to countries around the world, India alone accounts for 12% of corona cases. India is the third most corona affected country. In this period of corona infection, the Drugs Controller General of India (DCGI) has approved limited emergency use of ‘Alzumab’ (Itolizumab) for moderate to severe patients with COVID-19.
According to the Union Ministry of Health, ‘Alzumab’ (rDNA origin) is a monoclonal antibody that has already been approved for use in chronic plaque psoriasis. DCGI has now approved limited emergency use of this ‘Alzumab’ based on clinical trial data.
What is ‘Alzumab’?
Since 2013, M / s Biocon has been manufacturing and marketing this drug for the treatment of patients with moderate to severe chronic plaque psoriasis under the brand name ‘Alzumab’. This indigenous drug has now been remade for Covid-19.
M / s Biocon has presented to the DCGI the results of Phase II clinical trial in patients with Covid-19. The results of these tests were discussed in the Subject Expert Committee of DCGI’s office. The average cost of treatment with this indigenous drug i.e. tocilizumab is lower than that of comparable drugs that are part of the ‘investigational therapy’ indicated in the Clinical Management Protocol for COVID-19 of the Ministry of Health and Family Welfare.
Can give life-giving to serious patients-
After detailed deliberations and in keeping with the recommendations of the committee, DCGI has approved for the treatment of cytokine release syndrome (CRS) in patients with moderate to severe acute respiratory pain symptoms (ARDS) caused by COVID-19. Has decided to allow the drug to be marketed under limited emergency use of the drug subject to informed consent, a risk management plan, to be used only in the hospital, etc.
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