In India, Assam is the first state to procure a drug named 'Itolizumab' which can be used for the treatment of COVID-19 patients with moderate to severe psoriasis. Itolizumab with the trade name Alzumab is a drug approved by the Central Drugs Standard Control Organization (CDSCO) for the treatment of patients infected by the novel coronavirus. The SARS-CoV-2 virus affects individuals by triggering the immune system to generate a large number of cytokines which can attack vital organs like lungs, etc. and can lead to multiple organ failure or death. This is where Itolizumab seems to help the affected individuals. According to the state health ministry, Assam is the first state to have acquired Itolizumab just three days after the CDSCO approval.
However, the drug has gone through several controversies. Itolizumab was approved to treat COVID-19 on July 11th by the Drug Controller General of India (DCGI). However, it is not a newly introduced drug and has been there for a long time. It was approved in 2013 for treating psoriasis. According to Balram Bhargava, the Director-General of the Indian Council of Medical Research (ICMR), "A lack of sufficient evidence from clinical trials fails to prove that drugs like Itolizumab reduces mortality in COVID-19." The drug faced further controversies related to its tests and trials as its approval was based on favorable data received from a controlled, randomized clinical trial on just 30 patients from the hospitals of Mumbai and Delhi. 20 out of 30 patients, who were treated with Itolizumab, portrayed significant improvement in their condition and no mortality was witnessed. However, the rest of the 10 patients were treated with compromised antivirals; a standard care with hydroxychloroquine and oxygen therapy and in this trial, 3 patients had died. Critics have wondered if the trial was underpowered due to the small sample size.
The state government should have addressed the media on the efficacy of the drugThere is also a clear absence of phase 3 trials for this drug. Itolizumab is produced by a Bangalore based pharmaceutical company named Biocon Limited. The DCGI has waived Biocon's need to conduct phase 3 clinical trials and allowed the company to conduct post-marketing surveillance, also called Phase 4. However, experts across the country have reiterated the need of Phase-3 stating the complex nature of the COVID-19 disease. "Given this backdrop, the Assam Government should have been more cautious and discerning. At least there should have been a press meet addressed by top medical experts of the state to explain the efficacy of this drug," says Rima Bordoloi a practicing veterinary doctor.
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