The coronavirus pandemic is getting worse as the days go by, and the world is in dire need of a solution. Till the time a vaccine is discovered, pharmaceutical companies across the world are carrying out drug trials to test the effectiveness of various drugs against coronavirus. In the last few months, we have seen drugs such as hydroxychloroquine, favipiravir, dexamethasone and remdesvir being used to treat emergency coronavirus patients. Today, the Drug Controller General of India (DCGI), gave its approval to a plaque psoriasis drug named Itolizumab (ALZUMAb) to treat emergency coronavirus cases.
What is Itolizumab?
Itolizumab is a drug primarily used to treat psoriasis. Psoriasis is a chronic disease wherein some skin cells grow uncontrollably and result in red patches on elbows and knees. The drug is currently manufactured by a Bengaluru based pharmaceutical giant named ‘Biocon.’ It was approved as a treatment drug for psoriasis in 2013.
Why Did DCGI Approve Itolizumab?
The coronavirus works by inducing an acute immune response in moderate to severe patients. This leads to a surge in the number of cytokines (substances secreted by immune cells) aka ‘cytokine release syndrome’ or ‘cytokine storm.’ This surge ultimately damages various organs of the body and can even lead to multiple organ failure.
DCGI has approved itolizumab as a new biologic therapy to treat cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) patients with coronavirus. It was approved on the basis of results seen in randomized trials carried out at several hospitals in Mumbai and New Delhi. The dosage approved is that of 25mg/5ml injections.
How Does Itolizumab Work?
Itolizumab is the first new age biologic therapy approved globally for treating severe coronavirus patients. It works by modifying the body’s immune response. A class of immune cells, known as T-lymphocytes have a protein on their surface named CD6 receptor. Itolizumab binds with CD6 receptor and blocks the activation of T-lymphocytes. This further prevents the release of large number of cytokines or ‘cytokine storm’ and thereby, decreases the immune response. Itolizumab’s novel mechanism of treating the condition of ‘cytokine storm’ in coronavirus patients, earned it the DGCI’s approval.
At a virtual press conference, Executive Chairperson of Biocon, Kiran Mazumdar-Shaw, said, “ALZUMAb has a seven-year track record of of safety as doctors in India have been prescribing this biologic to treat acute psoriasis and ensure a better quality of life for patients and now we will be able to save many critically ill coronavirus patients.”
She further assured the people that even though the sample size of the trials was only 30 patients, the regulatory process was extremely vigorous and so were the scientific discussions.
Furthermore, the DCGI has exempted the itolizumab from Phase-III human trials and has allowed the company to directly conduct Phase-IV trials. To this, Biocon CMO, Dr. Athalye said, “Itolizumab is not a new drug and has been approved in India since 2013. We had done Phase-II and Phase-III trials and got the approval. In the past seven years, it’s been used in psoriasis, and we know how the mechanism works.”
According to the results of the trials conducted at Mumbai and New Delhi, the drug was able to effectively reduce the ‘cytokine storm’ in ARDS patients with coronavirus. Itolizumab met the primary expectations for a decrease in mortality rate, along with secondary expectations for efficacy and biomarkers (indicators to measure severity of a disease).
According to Biocon and DCGI, each vial of the drug will cost Rs 7950. Furthermore, based on an average body weight of 60 kg, the therapy will consist of four doses, amounting to a total of Rs 32,000.
While only time can tell more about the efficacy of itolizumab in treating the deadly coronavirus, we hope that we see some positive results. Till then, the government has requested everyone to follow social distancing guidelines and stay safe.