Biocon gets DGCI nod to market Itolizumab for Covid treatment

Our Bureau Bengaluru | Updated on July 11, 2020

Signage for Biocon Ltd,   -  Bloomberg

Biocon Ltd. said on Saturday it has received the Drugs Controller General of India’s (DCGI) approval to market Itolizumab Injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe ARDS (acute respiratory distress syndrome) patients due to Covid-19.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world to treat patients with moderate to severe Covid-19 complications. Biocon has re-purposed 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, a statement from the company said.

Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.

The SARS-CoV-2 virus has been observed to induce an overreaction of the immune system, generating a large number of cytokines that can cause severe damage to the lungs and other organs, and, in the worst scenario, multi-organ failure and even death, the statement said.

Clinical trial study

The approval of Itolizumab, from the DCGI, is based on the results from the successful conclusion of a randomized, 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 a reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved.

“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,” Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said.

“The randomized 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,” Mazumdar-Shaw said.

“Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in Covid-19 patients. I am pleased that our R&D and clinical teams delivered on this promising hypothesis in such a short period of time. It is a proud moment for all of us at Biocon and we would like more and more patients to benefit from this therapy."

“ALZUMAb has a seven-year proven track record 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 Covid-19 patients with our drug,” she added.

Recommendations and results

Dr Suresh Kumar, Medical Director, Lok Nayak Hospital, Delhi said: “ The hospital was one of the sites of the Itolizumab study wherein we used Itolizumab to treat eight patients. These patients did extremely well even with a single dose of Itolizumab. Patients who were with initial oxygen saturation of less than 80 per cent and were put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab.”

“I sincerely believe Itolizumab will not only help in reducing morbidity and mortality of Covid-19 patients but will also help us in judiciously managing healthcare resources like ICUs and ventilators for critically ill patients,” Kumar adds.

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 after administering Itolizumab. These outcomes were quite evident with one dose of Itolizumab when administered before the ‘cytokine storm’ set in. Most of the patients have well tolerated the drug.”

Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said: The drug demonstrated a statistically significant advantage over the control arm, in one-month mortality rate. Key efficacy parameters such as PaO2 and SpO2 (oxygen saturation) improvement without increasing FiO2 (oxygen flow) also showed a statistically significant advantage for Itolizumab arm over the control arm. All the patients on Itolizumab arm were weaned off oxygen by day-30, and none needed ventilator support, unlike the control arm. Key secondary endpoints of clinical markers of inflammation such as IL-6, TNF-α, serum ferritin, d-dimer, LDH and CRP showed clinically significant suppression post-dose and correlated well with clinical improvement in symptoms and chest x-ray images. Itolizumab was overall well tolerated and was found to be safe. Itolizumab when administered to patients with moderate to severe ARDS due to Covid-19, prevents morbidity and mortality due to cytokine storm. :

Itolizumab’s unique mechanism of action of immunomodulation involves binding to the CD6 receptor and blocking the activation of T lymphocytes, which in turn suppresses the pro-inflammatory cytokines, thus reducing the cytokine storm and deadly inflammatory response.

Biocon launched ALZUMAb (Itolizumab) in India in 2013 for the treatment of chronic plaque psoriasis. Many patients have benefitted from this novel therapy.

Published on July 11, 2020

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