Biocon to furnish more data for consideration of Itolizumab in treating COVID patients
Bengaluru: After facing rejection from the Health Ministry, Bengaluru-based drugmaker Biocon is now preparing to present 'more data' for consideration of its psoriasis drug- Itolizumab for treating Covid-19 patients, in order to enable the national Covid-19 task force to reconsider its decision on inclusion of Itolizumab in the clinical management protocol.
This comes days after the issue of including the drug in the clinical protocols was discussed in a meeting held on Friday. A majority of the members of the task force opined that there was not enough evidence currently to get the drug included in the clinical management protocols for COVID-19, despite securing approval from the Drugs Controller General of India (DCGI).
Biocon has been manufacturing and marketing Itolizumab, a monoclonal antibody, for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013, under the brand name ALZUMAb. It had repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody for the treatment of CRS in moderate to severe ARDS patients due to COVID-19.
To check the efficacy of the drug on COVID, the company has so far done a phase 2 study on 30 Covid-19 patients. However, the drugmaker sparked a controversy after it got an exemption from the DCGI from conducting the Phase 3 trial of the drug. It stated, " "Based on the encouraging study results of the pivotal Phase 2 conducted by Biocon in India, our US-based partner, Equilllium, is planning to conduct a global randomized controlled clinical trial of Itolizumab in Covid-19 patients for which it will file a US investigational new drug application (IND) soon."
As per a recent media report in The Print, Biocon has now applied for Phase 4 trial done as "post-marketing surveillance". It had also announced plans for a 200-patient, pan-India Phase 4 trial to be conducted across 10-15 hospitals".
"The study protocol has been submitted to the DCGI and we will commence the trial soon. The results from Phase 4 will create a larger body of evidence for the efficacy of Itolizumab in Covid-19 complications," the company's spokesperson told The Print.
After failing to please the authorities, Biocon has now decided to share more data as "evidence", which it has derived from off-label use (ie.doctors have prescribed the drug after taking the consent of the patient on compassionate grounds) of the drug on 1,000 patients.
"The national Covid-19 task force needs to see more evidence and we will provide them a large sample of real-world data to enable the committee to reconsider its decision on inclusion of Itolizumab in the clinical management protocol," the spokesperson told the daily.
"The drug has been used on nearly 1,000 patients across the country and generated good outcome data, " he added.