India's COVID-19 drug approved for emergency use after trial on only 30 patients
New Delhi: India's COVID-19 drug Itolizumab manufactured by Bengaluru-based Biocon Limited has been approved for emergency use for treating COVID-19 patients based on randomised clinical trial on just 30 patients across four centres, say reports.
Itolizumab is an existing drug that is currently used to treat psoriasis. The Drug Controller General of India (DCGI) has approved the drug for emergency use to treat patients.
Biocon Limited's COVID-19 drug will be available in the markets as ALZUMAb and one vial of the medicine will cost Rs 8,000. According to Biocon, a COVID-19 patient will have to be administered with four vials at a cost of Rs 32,000.
According to the company, the clinical trials have met the primary endpoint of reducing mortality and increase oxygen levels in patients.
To back the trial claims of the company, it has revealed that out of 30 patients, 20 were in interventional arm of the clinical trial and showed significant improvements in their conditions and no deaths were reported among the enrolled patients of the trial.
In other part of the randomised trial, patients were given standard care comprising of antivirals, hydroxychloroquine and oxygen therapy. In that trial, three out of 10 patients while the others survived.
According to various reports, the clinical trials of the COVID-19 trial started in May and the company has not shared any data of its clinical trials yet on any public domain.
All 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 and results were submitted to Clinical Trials Registry.