Biocon Ltd’s psoriasis drug, Itolizumab, re-purposed for COVID-19 and headlined as “breakthrough drug” for treating the moderately sick and the severely ill, appears to have been tested on too few patients to reliably conclude on its benefits, according to a review by The Hindu of data presented by the company to the Drug Controller General and comments by independent experts,who’ve seen the data.
To test the drug’s efficacy at preventing deaths or improving health outcome, the company recruited 30 patients across four hospitals, 20 of whom were given it along with the “standard of care treatment’ and 10 were given only standard of care. In the set of patients that got the drug, nobody died. Of the 10 who didn’t get the drug, three died. That nobody on the drug died was significant proof of the its success, said company officials.
Regulator’s approval
On July 11, Biocon announced that it had received the regulator’s approval to use the drug for emergency use in cases where the infection caused a cytokine storm, namely an uncontrolled attempt by the immune system to neutralise the virus that often ended up damaging the lungs and other organs and even death. Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru.
With such a small sam