Biocon's coronavirus drug for emergency use given approval after trial on only 30 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 coronavirus patients on Saturday.
The company revealed on Monday 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 acute respiratory distress on the basis of its clinical trials on only 30 patients across four centers.
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, the health ministry said.
"This indigenous drug has now been repurposed for coronavirus," the health ministry said in a statement on Saturday.
Biocon has also claimed that the clinical trials, conducted on only 30 patients, according to a report in News18, reduced mortality, improved oxygen levels, and reduced hyper-inflammation in the body.
The firm presented the phase II clinical trial results to the drug regulator which were deliberated upon by the Subject Expert Committee of the DCGI's office. The company markets the drug as ALZUMAb.
The company further said 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.
At least 10 patients who were given antivirals, hydroxychloroquine, and oxygen therapy. Of them, three died and seven survived. The company, however, has not shared any data.
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.
Dr. Suresh Kumar, Medical Director of Lok Nayak Hospital, told News18 that 11 patients were enrolled for the trial and the results were encouraging.