Bangalore-headquartered Biocon may consider applying for full marketing authorisation for itolizumab, a novel antibody product used to treat Covid-19 patients, in India.
If the Drugs Controller General of India (DCGI) gives a nod for marketing authorization, itolizumab (brand name Alzumab) will become the first drug to have full authorization for use in Covid-19 patients. So far, repurposed drugs, such as Gilead’s remdesivir (an antiviral) or Roche’s tocilizumab (an antibody), have emergency use authorizations in different countries.
Arun Chandavarkar, managing director of the Bengaluru-headquartered company, said: “We expect results from the phase 4 study on itolizumab by the end of this quarter. This would be real-world data from around 300 patients.”
A phase 4 study is studying the use and impact of the drug in real-world scenarios. This happens after a drug has been approved and is available in the market. Phase 4 studies help to answer key questions like whether the drug has any side effects that were missed in the clinical trials, or how well the drug or treatment works over a long period.
“Based on these results, we may evaluate options to file for full authorization of the drug for use in Covid-19 patients. As of now, Alzumab has an emergency use authorization (EUA) from the DCGI. The data from phase 4 study may help to get a full marketing authorization contingent to DCGI approval,” Chandavarkar said.
Doctors have used Itolizumab across the country during the second wave of the pandemic. Biocon said dosing the right patient at the right time was extremely critical for favourable outcomes with itolizumab.
The results from the phase 4 study may also help the drug to be included in the standard of care (SoC) protocol for Covid-19. The Indian Council of Medical Research (ICMR) protocol for Covid-19 treatment does not include the drug at the moment. The drug already has a marketing authorization for treating psoriasis, an auto-immune disorder, since 2013.
Itolizumab selectively targets the CD6 protein found in the T-cell, which is a type of white blood cell that plays a key role in the body’s immune response. In case of Covid-19 infection, due to activation of these T cells, body’s immune system goes on an overdrive, a process known as ‘cytokine storm’ that causes inflammation and organ damage.
By binding to CD6, itolizumab regulates the T-Cell activation, and thus causes reduction in the synthesis of pro-inflammatory cytokines. So far, around 27,000 Covid patients have been administered itolizumab in India. Apart from Biocon, Mumbai-based Sun Pharma, too, markets the drug under their brand Itolizac.
“We had stepped up production to address the rise in demand in the second wave of the pandemic. While we hope that the Covid situation in India improves without another wave of infections, we are fully geared to meet patient needs if there is a surge in demand,” a company spokesperson said.
Biocon’s Covid-19 portfolio includes remdesivir for mild-to-moderate patients, IItolizumab for moderate-to-severe patients and CytoSorb for critical patients. More than 50,000 patients cumulatively benefited by the end of Q1FY22 through our Covid care portfolio, the company said.
Besides India, the drug is now being developed in other markets as well. “Equillium, our US-based partner, had an End-of-Phase 1 meeting with the US FDA, which confirmed a path to advance Itolizumab into a single Phase 3 pivotal study for Acute Graft-versus-Host Disease (aGVHD) to support their Biologics License Application (BLA),” the company said.
The study is expected to commence in the fourth quarter of calendar 2021. Biocon owns the European rights for Itolizumab. The Committee for Orphan Medicinal Products gave an orphan designation to itolizumab for the treatment of acute and chronic GVHD recently.