Daily Management Review

Indian Drug Regulator Approves India’s Biocon's Itolizumab For Treatment Of Covid-19


Indian Drug Regulator Approves India’s Biocon's Itolizumab For Treatment Of Covid-19
In a landmark move in the fight against Covid-19, Indian drug regulator the Drug Controller General of India approved the use of Itolizumab on Covid-19 patients, the disease caused by the novel coroanvirus. The drug has been developed by the Indian biotech company Biocon.
This drug is already present in the market and is used for treatment of patients with psoriasis, a debilitating skin ailment.
But ht is the link between the two ailments - psoriasis and Covid-19 that has prompted regulators to approve the use of the drug Itolizumab?
According to experts, the ability of the drug to tone down the aggressive and self-damaging response of the body's immune system is the primary characteristic that has made the drug effective against Covid-19. When people get infected by with the coronavirus, the immune system of the body starts to overreact as the virus multiples and progresses within the body. In medical terms, this situation is called the cytokine storm which has now become quite commonly used since the Cvodi-19 assumed pandemic proportions.
But the approval also came with a caveat. The Itolizumab drug has been prescribed to be administered only in moderate to severe cases and never in the early stage of the viral attack because the drug helps to calm down the immune system thereby reducing immunity. Doctors say that this makes it important for the cautious administration of the drug under medical supervision since this medicine is expected to be used only at a stage of Covid-19 infection when a patient needs oxygen support. The body needs a strong immune system to fight the virus during the early stage when the virus strikes the body.
While this drug has been developed by the Indian pharma company Biocon, the molecule that makes up this drug was originally licensed as an early stage asset from the Centre for Molecular Immunology, a cancer research institute in Cuba.
This drug was first developed by Biocon in 2006 and it was approved for treatment of psoriasis under the brand name ALZUMAb by the Indian drug regulators in 2013.
Biocon has managed to move from the stages of application for the commencement of trials on coronavirus patients with the drug to being granted the final approval for commercialization within a period of just 120 days, said Biocon founder and chairperson Kiran Mazumdar Shaw.
"Everyone has taken this up with a sense of urgency," she says with a palpable sense of relief.
The price of one vial of the drug is about Rs 7,950 ($115) and patients will typically need four vials which takes the overall costs of the treatment to a maximum of about Rs 32,000 ($450), said Shaw.
The company had conducted trails in four centres in the Indian cities of Mumbai and Delhi, Shah said.
"We also had an open label randomised trial which means some patients were kept on standard of care and another set of patients given this drug on top of standard of care (which could be anything from paracetamol to steroids) and all the patients on Itolizumab recovered."
"The day after the drug was administered, the oxygen support levels started coming down and within two weeks most recovered were discharged and that is why, it is so significant," she says adding, "Had this happened in the US, people would be shouting from rooftops."