Coronavirus News: Amid rigorous research to come up with a vaccine that can bid adieu to the deadly coronavirus, Bengaluru-based pharma Biocon’s Itolizumab has got the approval for “restricted emergency use” to treat COVID-19 patients on the basis of clinical trials on only 30 patients across only four centres. Also Read - Sanjay Dutt Hospitalised in Mumbai Due to Breathlessness, Has Been Tested Negative For COVID-19
The Directorate-General of India (DGCI) gave a go-ahead to the biopharmaceutical company on Saturday to treat patients who have “moderate to severe” acute respiratory ailments caused by the viral infection. Also Read - Zimbabwe Cancel T20I Series Against Afghanistan Due to COVID-19 Pandemic
Notably, Biocon has already been manufacturing the indigenous drug Itolizumab to treat patients with severe chronic plaque psoriasis since 2013 under the name Alzumab. A relatively cheaper drug when compared to its competitors, the DGCA approval has repurposed it following the Phase-II clinical trial to treat coronavirus patients. Also Read - COVID-19: Centre Raps 13 Districts For High Mortality Rate, 5 of Them Are in Bengal | Check List
“The results of these trials were deliberated in the Subject Expert Committee of DCGI’s office,” the Ministry of Health and Family Welfare (MoHFW) said.
“Details of the primary endpoint of mortality, other key endpoints of lung function such as improvement in PaO2 and O2 saturation were presented. Key inflammatory markers IL-6, TNFI etc, were presented to have reduced significantly with the drug thereby preventing hyper- inflammation in COVID-19 patients,” the ministry added.
When compared to a range of other drugs constantly being brought for human trials, scientific experts believed, Biocon’s Itolizumab was granted approval for “emergency use” even after the low enrollment numbers.
According to News18 report, Dr Sandeep Athalye, Chief Medical Officer at Biocon Biologics, said that the reason it was approved easily was because it is a “label extension of an existing product”.
He went on to say that they went ahead seeking approval from the DGCA only because of the “magnitude of effect in reducing mortality” in the small number of trials.