'Alzumab' given approval for restricted emergency use to treat Coronavirus patients
The Drug Controller General of India (DGCI) had given approval to Bengaluru based Biocon's Itolizumab, a drug used to cure skin ailment psoriasis, for "restricted emergency use" to treat Corona virus patients on Saturday.
New Delhi: The Drug Controller General of India (DGCI) had given approval to Bengaluru based Biocon's Itolizumab, a drug used to cure skin ailment psoriasis, for "restricted emergency use" to treat Coronavirus patients on Saturday.
The company authorities said that the approval was given by India's drug regulator for emergency use of Biocon's Itolizumab drug on Coronavirus patients with moderate to severe sensitive respiratory distress on the basis of its clinical trials on only 30 patients across four centres.
"Biocon, a domestic biopharmaceutical company, has been manufacturing and marketing Itolizumab, a monoclonal antibody drug, for the treatment of patients with moderate to severe chronic plaque psoriasis since 2013 under the brand name 'Alzumab'. This indigenous drug has now been repurposed for Coronavirus," says health minister.
Accordng to sources, Biocon has also claimed that the clinical trials, conducted on 30 patients reduced mortality, improved oxygen levels, and reduced hyper inflammation in the body.
The company further added that 20 of the 30 patients, who had received the drug during the clinical trials, showed significant improvement. The trials had begun in May and 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 enroll any patient, a doctor from the hospital aware of developments said.
The company has also claimed that doctors and investigators in many parts of India have used 'Alzumab' to save patients and over 150 patients have recovered in Maharashtra, Gujarat, and Delhi.