Some comments regarding the approval in India of B
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Posted On: 07/14/2020 6:20:43 PM
Some comments regarding the approval in India of Biocon’s Itolizumab, a monoclonal antibody originally intended for plaque psoriasis. This is an immunomodulator. It binds to the CD6 receptor and blocks the activation of T lymphocytes, in turn suppresses cytokines quelling the cytokine storm.
How was this approved?? Read below:
Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month (similar to our S/C P3).
As reported by Biocon:
So, on basis of 30 patients and the fact that there were no deaths at one month on the drug arm and three in the placebo (note this was an open label randomized trial with standard of care for both arms in two hospitals), the drug received emergency authorization by the Drugs Controller General of India (DCGI) to treat cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) patients with Covid-19.
Talking about the statistical power of trials!!. This, statistically speaking, is NOT a good trial, there is no way that one could draw conclusions only from a p-number from such a low powered trial.
However, I am NOT judging here DCGI. Why?? Well, they saw some benefit, there are not many adverse effects, the drug can be produced in India, there is desperate need for a drug and the cost is manageable, 25000-30000 rupees per treatment ($330-$400).
So, an emergency situation deserves an emergency solution: approval.
Effectively the death of three patients decided the approval of a COVID drug for 1.4 Billion people.
FDA: are you listening ????
How was this approved?? Read below:
Biocon conducted a randomized, controlled, open-label study at four hospitals in India, enrolling a total of 30 hospitalized COVID-19 patients with moderate to severe ARDS. Twenty patients were randomized to receive itolizumab plus best supportive care, while 10 patients received best supportive care alone. The primary endpoint was mortality at one month (similar to our S/C P3).
As reported by Biocon:
Quote:
• In the itolizumab arm there were no deaths and all patients have recovered; in the control arm three patients died and the remainder have recovered
• The mortality benefit observed in the itolizumab arm was statistically significant
• Consistent with the observed clinical improvement, patients who received itolizumab also experienced significant reductions in inflammatory cytokines such as IL-6 and TNFα
So, on basis of 30 patients and the fact that there were no deaths at one month on the drug arm and three in the placebo (note this was an open label randomized trial with standard of care for both arms in two hospitals), the drug received emergency authorization by the Drugs Controller General of India (DCGI) to treat cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) patients with Covid-19.
Talking about the statistical power of trials!!. This, statistically speaking, is NOT a good trial, there is no way that one could draw conclusions only from a p-number from such a low powered trial.
However, I am NOT judging here DCGI. Why?? Well, they saw some benefit, there are not many adverse effects, the drug can be produced in India, there is desperate need for a drug and the cost is manageable, 25000-30000 rupees per treatment ($330-$400).
So, an emergency situation deserves an emergency solution: approval.
Effectively the death of three patients decided the approval of a COVID drug for 1.4 Billion people.
FDA: are you listening ????
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