India’s first indigenous biologic, Biocon’s ALZUMAb gets approval for COVID-19 treatment, says GlobalData

Following the news that India-based biopharma company Biocon’s plaque psoriasis drug itolizumab (ALZUMAb) has secured approval from the Drugs Controller General of India (DCGI) for emergency use in COVID-19 patients;

Nag Madhavi, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“ALZUMAb is a novel humanized anti-CD6 monoclonal antibody, which was launched in 2013 for the treatment of psoriasis in India. It is the first biologic in the world to get approval for COVID-19 complications; however, its use is associated with certain conditions and hence requires informed consent from the patients and an effective risk management strategy. DCGI has granted restricted emergency use of itolizumab for the treatment of cytokine release syndrome (CRS) in patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19.

“The approval is based on the positive Phase II results from the randomised controlled trials, with thirty patients across four hospitals in Mumbai and Delhi. At the end of first month, 20 patients on itolizumab were discharged whereas three out of 10 patients on best standard of care died. This immunomodulator has been repurposed for the treatment of COVID-19 as cytokine storms or acute inflammatory responses are considered to be one of the main drivers of mortality in COVID-19 patients

“Itolizumab acts by binding to CD6 receptor and down-regulating T-cell activation leading to suppression of pro-inflammatory cytokines, thereby reducing cytokine storms. Thus, the drug must be administered with caution, and only to moderate to severe patients only and not in the early stage of the disease. Additionally, Biocon’s partner Equillium plans to conduct global clinical trials of itolizumab for COVID-19.

“According to the GlobalData COVID-19 dashboard, as of 14 July 2020, India has 878,254 confirmed cases, and the dashboard forecasts 2,648,425 confirmed cases in India in a low transmission risk scenario by 20 July 2020.

“ALZUMAb is an intravenous therapy priced at INR7,950 (US$106) per vial, and the overall treatment cost is estimated to be INR32,000 (US$426). Reportedly, the average cost of therapy of itolizumab is considered to be lower than tocilizumab and other comparable drugs under investigation mainly for the severe patients as part of the clinical management protocol for COVID-19 in India.

“Currently, the approved emergency use drugs such as tocilizumab and remdesivir are exorbitantly priced in India mainly due to black marketing which are associated with safety concerns. Notably, even with emergency use approvals for several drugs in India, oxygen support, corticosteroids and anti-coagulants continue to be the mainstay for treatment.

“Even though the trial results indicate a reduction in mortality, there are concerns over itolizumab’s efficacy due to the low number of patients enrolled for the trial. Hence, this could be a limiting factor for its usage.”

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