Biocon's Covid-19 Drug Itolizumab Approved for Emergency Use after Trial on Only 30 Patients
Bengaluru-based Biocon Limited’s Itolizumab drug that was granted emergency use approval for treating Covid-19, was cleared on the basis of a randomised clinical trial of just 30 patients across 4 centres. The firm revealed this yesterday.
The trials were carried out at Lok Nayak Jai Prakash Narayan Hospital and All India Institute of Medical Sciences in Delhi and at King Edward Memorial (KEM) Hospital and BYL Nair Hospital in Mumbai.
Nanavati Hospital, which was listed as one of the trial sites, could not enrol any patient, a doctor from the hospital aware of developments said.
Data shared by the company’s top officials and data available on the Clinical Trials Registry website showed that clinical trials to test the efficacy of the drug began in May.
The company has claimed the clinical trials met the primary endpoint of reducing mortality and other key endpoints of improved oxygen levels and reduction in hyper-inflammation in the body.
To back its claim, the company sought to point out that of the 30 patients, 20 patients who were in the interventional arm of the trial or those who got Itolizumab, showed significant improvement in their condition and no mortality occurred in this arm of the trial.
Due to the low numbers of enrollment in the clinical trials, some in the scientific community have raised questions on the approval granted for its emergency use.
The company, however, has not shared any data yet in the public domain through a peer-reviewed paper.