Biocon Limited, an Indian pharmaceutical company based in Bengaluru, has received the Drug Controller General of India’s (DCGI) approval to market ‘Itolizumab,’ a drug previously used to treat chronic plaque psoriasis, for restricted emergency use on COVID-19 patients with moderate to severe acute respiratory disease.
When a person is infected with the coronavirus, it rapidly multiplies and progresses within the body, triggering an extreme reaction from the immune system. This is where Itolizumab helps — the intravenous injection works on toning down the aggressive response which can be self-damaging.
Here are 10 things to know about Itolizumab.
Itolizumab was launched in 2013 under the brand name Alzumab to treat moderate to severe chronic plaque psoriasis. It has been now repurposed for the treatment of COVID-19 complications.
The injection can be used as an immuno-moderator, in cases of emergency, to prevent and treat cytokine storms. Cytokines are small proteins secreted by immune cells to communicate and alter the actions of other immune cells. The SARS-COV-2 virus has been observed to induce an overreaction of the immune system, generating large numbers of cytokines that can cause severe damage to the lungs and other organs.
It is administered as a single shot to moderate/moderately severe patients the moment it is suspected that they may need ventilator support.
Since it helps to calm the immune system down, it needs to be given only in moderate to severe cases, when the patient needs oxygen support, and never in the early stages of viral attack.
Itolizumab will be manufactured and formulated as a 25 mg and 5 ml intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.
One vial is currently priced at Rs 7,950 and each patient’s requirement would depend on the severity of their condition.
The clinical trials were conducted in four centres. Two in Mumbai — King Edward Memorial hospital, BYL Nair Hospitals, and two in Delhi — Lok Nayak Hospital and AIIMS under the guidance of an expert committee consisting of pulmonologists, pharmacologists, and medical experts.
The approval was given after the trial on 30 COVID-19 patients was found satisfactory by the expert committee.
According to a press release from Biocon, an open-label randomised trial was also conducted which means some patients were kept on standard care and some were given ‘Itolizumab’ drug on top of standard care. All the patients on this drug responded positively and recovered. The control arm that did not receive Itolizumab passed away.
As per the DCGI, the novel drug can be used only in hospital set-up and requires the consent of patients and a risk management plan.
“At a time when there is no specific treatment for patients against the disease, it is a positive sign that patients, including those who were on ventilators with low chances of survival, recovered completely when treated with Itolizumab,” says Dr Suresh Kumar, Medical Director at Lok Nayak Hospital New Delhi. He is hopeful that Itolizumab will not only help in reducing morbidity and mortality but will also help to manage healthcare resources like ICU and ventilators.
Disclaimer: Those suffering from symptoms of Covid-19 should not self-administer the drug.
(Edited by Gayatri Mishra)