Biocon's Itolizumab approved for Covid-19 treatment: All you need to know

NEW DELHI: Biotechnology major Biocon has said that it will launch biologic drug 'Itolizumab' for the treatment of moderate to severe Covid-19 patients at a price of around 8,000 per vial.
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications, Biocon said.
Here is all you need to know about the drug:
What is Itolizumab?
Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe Covid-19 complications, Biocon had said in a regulatory filing.
It is a clinically proven therapy for the Covid-19 patients with acute respiratory distress syndrome (ARDS), Biocon executive chairperson Kiran Mazumdar-Shaw said.
She added that the drug has got successful results from a multi-centric, two armed randomised pivotal trial conducted to study the efficacy and safety of Itolizumab in Covid-19 complications.
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.
Itolizumab will be manufactured and formulated as an intravenous injection at Biocon's bio-manufacturing facility at Biocon Park in Bengaluru.
How does the drug work?
Shaw said the beauty of this drug is it is working upstream, which means it actually starts regulating the immune system, rebooting the immune system and it starts down regulating the immune system, saying, do not make such pro-inflammatory cytokines start slowing down.
She added that the body then recovers completely to fight the virus.
By effectively controlling therefore hyper activation of the immune system prevents morbidity and mortality related to the cytokine storm.
Treating Covid-19
The cost of per vial is Rs 7,950. As most patients need 4 vials, the cost of the therapy is around Rs 32,000, Mazumdar-Shaw said.
The average cost of treatment with Itolizumab is also less than comparable drugs which are part of the "Investigational Therapies" indicated in the Clinical Management Protocol for Covid-19 of the Union ministry of health.
The drug will be manufactured and formulated as an intravenous injection.
'Original innovative' Indian drug
According to Shaw, Itolizumab is an original innovative Indian drug, which Biocon has licenced from Cuba 20 years ago.
We developed it in India. We actually did a lot of research in India, she said.
We actually did clinical trials in India, and it is made in India, innovated in India, drug, which we have licenced to a US company, which is also doing trials with the drug. And we are very proud that this is actually an original first in class drug, Shaw said.
Stating that there is no other company in the world that has an anti-CD6 antibody, Shaw said Itolizumab is a unique drug.
Ramping up manufacturing
On being asked if the company is ramping up the capacity to manufacture more vials on account of the pandemic, Biocon said: "We have the manufacturing capacity and the supply and distribution network in place.
Biocon said it is looking to ramp up production capacity to meet the expected surge in demand.
Thr drug is already in market, and Biocon will be supplying to hospitals as per protocol against a medical prescription and patient consent form.
Approval from the DCGI
The company received approval from the the Drugs Controller General of India (DCGI) to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe ARDS due to Covid-19.
The DCGI gave permission for the use of the Itolizumab drug after Biocon presented the Phase-II clinical trial results generated in Covid-19 patients.
(With agency inputs)