Biocon gets DCGI nod for use of Itolizumab for treatment of Covid-19 patients

Biocon Ltd, a Bengaluru-based biopharmaceuticals major, on Saturday said it has received approval from the Drugs Controller General of India's (DCGI) to market Itolizumab injection (25 mg/5mL solution) for emergency use for the treatment of cytokine release syndrome in moderate to severe ARTDS (acute respiratory distress syndrome) patients due to Covid-19.

Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications, the company said in a statement. 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.

Biocon will manufacture and formulate Itolizumab as an intravenous injection at Biocon's bio-manufacturing facility at Biocon Park in Bengaluru.

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, Biocon said.

"I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with Covid-19," Kiran Mazumdar-Shaw, Executive Chairperson, Biocon said.

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.

Dr Suresh Kumar, Medical Director, Lok Nayak Hospital, Delhi said: “At the time of this Covid-19 pandemic, we do not have any specific treatment for patients who are losing the fight against the disease in spite of best supportive care. Lok Nayak 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% and would have been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged."

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.