Biocon's Itolizumab, which was developed in collaboration with Centre for Molecular Immunology (CIM) in Cuba has received a nod from the Drug Controller General of India (DCGI) for emergency, restricted use among moderate to moderate-severe COVID-19 patients.
The approval of Itolizumab happened on a 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.
Itolizumab, branded as Alzumab, was developed by the Kiran Mazumdar Shaw led Biocon in 2013 where it went through a 52-week phase-III multi-centre trial and was intended for the use of psoriasis. It is a 'humanised monoclonal antibody' of the IgG1 class, which targets the CD-6 cytokine receptor.
The MRP of the injection is Rs 7,950 per vial, and according to Biocon, each patient needs 4 vials, making the total cost to be Rs 32,000. Dr Hemant Thacker, Consultant & Senior Physician, Breach Candy Hospital, Mumbai discussed the efficiency of the drug in a discussion with BOOM.
Dr Thacker was one of the first physicians in Mumbai to use the drug. He says, "I recruited the first patient on compassionate grounds on 12 May. It was the patient's 6th day of needing more and more oxygen. There was a possibility of him going into a cytokine storm sooner or later. We used about 4 to 5 ampules or 100-125 milligrams. We usually give it once but it can be repeated in a week."
Drug Effectiveness
Dr Thacker then points out that the efficiency of the drug worked as well as Tocilizumab, another COVID-19 life saving drug which is used to inhibit cytokine storms and is not very easily available in the market, and is extremely expensive.
He says about the efficiency of the drug, "This drug blocked the action of the inflammatory cytokines, which were triggered by the irritation of the virus in the body. We've tried it on 25 patients so far."
Dr Thacker also has a word of caution, "Remember this is for moderate, moderate-severe, and severe COVID-19 patients that form less than 4-5% of the patient population. This is not a cure to COVID-19, but it is a way to reduce mortality rates."
He added, "We are hoping that this is one modality we can use in the cornerstones of our treatment against COVID-19."
Side Effects
Though Dr Thacker thinks there are no side-effects of the drug if it is given over a period of 6 or 7 hours, slowly, but he says overuse might be a potential problem. "If you give this drug very rapidly into three hours, you can get a problem with the patient getting an allergic reaction with shivering chills. We generally give it over 7 hours slowly then nothing happens."
"Till now, we have had no kidney shutdown, no other side effects in the long term. But then again, we've only had a two month follow-up the time. We'll know the long term effects after a period of 6 months," he added.
Dr Thacker says he has a word of advice. "The pandemic is far from over. It's advisable to exercise the same precautions of social distancing and wearing a mask till then."
Highlights
-Itolizumab is not a cure for COVID-19 but a way to reduce mortality rates.
-It can be administered over a period of 6 to 7 hours slowly, and no adverse effects have been seen since it has been administered in the last two months.
-Long term effects of the drug will be known after 6 months.
Catch the interview on YouTube or click on the link here.