DGCI approved life-saving Covid-19 drug to hit markets; priced at Rs 8,000 per vial
Bengaluru based biotech major Biocon on Monday announced that its drug Itolizumab, which will hit the market as ALZUMAb, has received permission from the Drugs Controller General of India for use in moderate to severe Covid-19 patients.
"It is the first novel biological therapy to be approved by the DCGI for treating patients with moderate to severe Covid-19 complications," the executive chairperson of the company Kiran Mazumdar Shaw said at a press conference.
Claiming that Itolizumab is a drug to save many lives, she said the DCGI gave permission for Biocon to market Itolizumab.
"It is an injection containing 25mg/5mL solution for emergency use in India for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ADRS) patients caused by the Covid-19," the Biocon chairperson said.
Shaw said the therapy costing Rs 32,000 is given to the patient in four vials with each vial priced at Rs 8,000.
Itolizumab is a clinically proven therapy for the Covid-19 patients with ARDS, she said, adding 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.
"Itolizumab is a breakthrough.
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 downregulating the immune system, saying, do not make such pro-inflammatory cytokines start slowing down," Shaw said.
She added that the body then recovers completely to fight the virus.
"By effectively controlling, therefore, hyperactivation of the immune system prevents morbidity and mortality related to the cytokine storm," she added.
According to her, this is an original innovative Indian drug, which Biocon has licenced from Cuba 20 years ago.
"And we developed it in India. We actually did a lot of research in India.
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.