Biocon’s Itolizumab, COVID-19 drug got approved by DGCA; just after 30 human trials…

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Drugs Controller General of India (DCGI) approved biopharmaceuticals company Biocon’s Itolizumab (ALZUMAb) which is a plaque psoriasis drug as an emergency use for COVID-19 patients. It is claiming that it will be treating moderate to severe coronavirus infected patients. It will cost around Rs 8,000 per vial

About ITOLIZUMAB!!

The company said in a regulatory filing that it is the 1st  drug novel biologic therapy that has been approved anywhere across the globe for the treatment of COVID-19 patients with moderate-severe complications. 

Kiran Mazumdar Shaw, the Executive Chairperson of Biocon said that clinical studies have proved this therapy for COVID-19 patients with ARDS i.e. Acute Respiratory Distress Syndrome.

The drug as been repurposed by Biocon, a monoclonal antibody (anti-CD6 IgG1) which was launched in the year 2013 in India and was named ALZUMAb. This was used for treating chronic plaque psoriasis. It can also be used in the treatment of CRS in moderate to ARDS in severely affected patients of the corona. CRS and ARDS happen due to COVID-19 suffering.

“ALZUMAb has a 7-year proven track record of safety as doctors in India have been prescribing this biologic to treat acute psoriasis and ensure a better quality of life for patients and now we will be able to save many critically ill COVID-19 patients with our drug,” said Shaw.

Biocon’s bio-manufacturing facility which is located at Biocon Park in Bengaluru will be manufacturing and formulating Itolizumab as an intravenous injection.

It is said that Biocon has licensed Itolzumab from Cuba twenty years ago and this is an original innovative Indian drug. 

Kiran said that they have developed and did a lot of research about the drug in India. They have done the clinical trials and innovated this drug in this very land but they have licensed it to a US company. The US company is also conducting trials for the same. She also expressed how proud they are about the drug to be an original first in class drug. 

There is no other company across the globe that possesses an anti-CD6 antibody, and this makes Itolizumab a unique drug.

 

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ITOLIZUMAB working…

The upstream working of the drug is its beauty, which means the drug begins the regulation and reboots the immune system, said Mazumdar Shaw. She also said that it starts down-regulating the immune system that does not make such pro-inflammatory cytokines to slow down. Her quoted statement was “Itolizumab’s unique mechanism of action made it an ideal candidate for treating the ‘cytokine storm’, which is a leading cause of death in COVID-19 patients.” 

She mentioned that after all this an individual’s body recovers completely and becomes ready to fight against the virus. 

By effectively controlling, the hyperactivation of the immune system prevents mortality and morbidity that is related to the cytokine storm.

ITOLIZUMAB treating COVID-19 (expense)

  • As earlier mentioned, the drug will be manufactured and formulated as an intravenous injection.
  • It will cost Rs. Seven thousand Nine hundred and fifty per vial and most of the patients will require 4 vials. Hence the entire cost of the therapy will be around Rs. Thirty-two thousand. 
  • If compared, the approximate cost of treatment with this drug is lesser than the drugs which are a part of the Investigational Therapies indicated in the Clinical Management Protocol for coronavirus of the Union Ministry of Health.

 Manufacturing rush…

“We have the manufacturing capacity and the supply and distribution network in place,” the company said when it was asked if Biocon is increasing the pace of manufacturing more vials on account of the ongoing emergency of the COVID-19 pandemic. 

To meet the expected surge in demanded the company is looking forward to ramp up the manufacturing capacity said Biocon.

The drug is already available in the market, and the hospitals will receive the drug supplies from the company as per protocol against a medical prescription and patient consent form.

DCGI approval

The Drug Control General of India approved Biocon to market the Itoizumab drug in injection form with 5ml/25mg solution for emergency use in the nation for treating Cytokine Release Syndrome (CRS) in moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to Coronavirus. 

The approval is based on favorable data received from a controlled, randomized clinical trial on just 30 patients which were conducted in the hospitals located in New Delhi and Mumbai. The trials were carried out in:

  • All India Institute of Medical Services
  • Lok Nayak Jai Prakash Narayan Hospital
  • BYL Nair Hospital
  • King Edward Memorial (KEM) Hospital

The primary endpoint of reduction in mortality, other essentials like improved oxygen level, and reduced hyper-inflammation in patients’ bodies were met by the clinical trials.

20 patients out of 30 patients, who were treated with Itolizumab portrayed significant improvement in their condition and no mortality was witnessed. On the other hand, the rest of the 10 patients were treated with compromised antivirals, standard care with hydroxychloroquine, and oxygen therapy. In this trial, 7 patients survived and 3 died. 

Shaw said, “Apart from 20 patients who recovered, many doctors and investigators in many parts of the country decided to use ALZUMAb available in the market in a bid to try and save patients. So far, over 150 patients have been rescued with Itolizumab or ALZUMAb in Maharashtra, Gujarat, and Delhi.”

Many questions have arrived because of the small number of enrollment in the clinical trials. 

A webinar briefing of Biocon was held this Monday, and the officials of the company were asked for their vision and criticism about the same. 

  • The dean of Indian College of Physicians and the principal investigator of the trial, Dr. Shashank Joshi said that “In a pivoted trial, when we want to answer a question, the minimum statistical number required is 30, and therefore, lot of people lot might still critique that 20 and 10 is too small a number. Yes, I agree with that, but as long as you apply a robust statistical design where Phase II and III have already been tried in 2013 on more than 500 patients, I think it gives us a proof of concept whether it is working or not. This small trial has given us insights on safety and efficacy.”
  • The Chief Medical Officer of Biocon Biologics, Dr. Sandeep Athalye said, “It is a label extension of an existing product. We have a lot of safety information over the last seven years. If we had not seen this magnitude of effect in reducing mortality, even in a small trial, then we would have expanded the trials. We have demonstrated the statistically significant differences and the regulators were convinced that the magnitude of the effect is high.” 
  • Medical Director of Lok Nayak Hospital, Dr. Suresh Kumar said “We had enrolled 11 patients for the trial. The results are encouraging. All the deaths happened in the control group. In the experimental group, there were no deaths, they showed good improvement.”

{statement source: News18}

After the presentation of Phase – II clinical trial’ s results generated on COVID-19 patients, Itolizumab drug got permission for use from DCGI. 

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