BENGALURU: The Drugs Controller General of India has approved the use of Biocon Ltd’s Itolizumab (ALZUMAb) injection (25mg/5mL solution) for emergency for treatment of Covid-19. The drug can be used in treatment of cytokine release syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) patients due to Covid-19.
Itolizumab is the first novel biologic therapy to be approved in the world for treating patients with moderate to severe Covid-19 complications. Biologic therapy involves using living organisms or substances derived from living organisms, or laboratory-produced versions of such substances to treat disease.
The SARS-CoV-2 virus — which causes Covid-19 — has been observed to induce an overreaction of the immune system, generating a large number of cytokines (immune system cells-secreted protein that regulate immunity inflammation, and blood cells production) that can cause severe damage to lungs and other organs, and, in the worst scenario, multi-organ failure and even death. Itolizumab drug has been found to be useful to treat this condition.
The DCGI’s approval for Itolizumab’s use is based on results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.The study focussed on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to Covid-19. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved, a Biocon release said.
Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody, launched in India in 2013 as ALZUMAb for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to Covid-19. Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru. But the price of the drug is not yet fixed.
Itolizumab has 7-year proven track record of safety: Kiran Shaw
Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said, “This positions India among the leading global innovators in their efforts to overcome the Covid-19 pandemic. The randomised control trial indicated that all the patients treated with Itolizumab (ALZUMAb®) responded positively and recovered. The control arm that did not receive Itolizumab unfortunately had deaths. Itolizumab is now approved for the treatment of CRS in patients with moderate to severe ARDS due to Covid-19. We plan to take this therapy to other parts of the world impacted by the pandemic…
The data is compelling and I am confident that this ‘first-in-class’ biologic will save lives and help reduce the mortality rate in our country.” She said ALZUMAb has a seven-year proven track record of safety as doctors in India have been prescribing it to treat acute psoriasis and ensure a better quality of life for patients and “now we will be able to save many critically ill Covid-19 patients with our drug”.
Dr Mohan Joshi, Dean, BYL Nair Hospital, Mumbai, said, “In our hospital, we have tried Itolizumab in many Covid-19 patients with moderate to severe ARDS and found significant improvement in clinical, radiological and inflammatory markers.
These outcomes were quite evident with one dose of Itolizumab when administered before the ‘cytokine storm’ set in. Most of the patients have tolerated the drug well. Given the growing surge of Covid-19 cases, I would recommend use of Itolizumab in moderate to severe complications in COVID-19.”
Dr Suresh Kumar, Medical Director, Lok Nayak Hospital, Delhi, said, “In the time of this Covid-19 pandemic, we do not have any specific treatment for patients who are losing the fight against the disease despite best supportive care. Lok Nayak Hospital was one of the sites of the study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose”.
As on Saturday evening, India has more than 2,89,656 documented active coronavirus infections and over 22,589 deaths.