Biocon's drug Itolizumab gets regulator nod to treat Covid-19 patients

The drug which has got approval to treat moderate to severe Covid complications will be manufactured as an intravenous injection at Biocon's Bengaluru plant

Biopharmaceutical major Biocon on Saturday said it has received the Drugs Controller General of India’s (DCGI) approval to market its novel biologic drug Itolizumab for treatment of patients with moderate to severe Covid-19 complications.

Biocon had developed and launched Itolizumab in 2013 in India under the brand name ALZUMAb to treat moderate to severe plaque psoriasis. The drug will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility in Bengaluru.

“This positions India amongst the leading global innovators in their effort to overcome the Covid-19 pandemic. The randomized control trial indicated that all the patients treated with Itolizumab responded positively and recovered. We plan to take this therapy to other parts of the world impacted by the pandemic,” said Kiran Mazumdar-Shaw, Executive Chairperson, Biocon.

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 clinical trials of Itolizumab conclude that the drug prevents cytokine release syndrome in moderate to severe acute respiratory distress syndrome patients due to Covid-19.

"Lok Nayak Hospital in Delhi 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 would have been put on ventilator support with little chance of survival, recovered completely when treated with Itolizumab and got discharged,” said Suresh Kumar, Medical Director, Lok Nayak Hospital.

Several other drugs such as Tocilizumab, Favipiravir and Remdesivir are being repurposed in India to treat Covid-19 patients. While Hetero is delivering Covifor (remdesivir) for the treatment of the virus at a maximum retail price of Rs 5,400 per vial, Cipla has launched the same drug under the name Cipremi at Rs 4,000 per vial. Glenmark has rolled out FabiFlu which is the first oral Favipiravir-approved medication in India for the treatment of Covid-19. FabiFlu is used in treatment of mild to moderate Covid-19 patients. Tocilizumab, which is a rheumatoid arthritis drug, is also being imported and distributed by Cipla in India to treat coronavirus. However, with cases rising, there is acute shortage of the drug in the market.

“We desperately need Itolizumab as Tocilizumab is no longer available in Bangalore. We have been begging hospital to hospital for even one dose,” said Satyanarayana Mysore, HoD of interventional pulmonology and sleep medicine Manipal Hospitals. He also hoped the price of Itolizumab would be much lower than Tocilizumab which costs Rs 40,000 per injection of 400 mg.