Flutter Over Biocon’s Repurposed Psoriasis Drug For COVID-19 In India
Emergency Use But Some Concern Over Small Trial
Executive Summary
Biocon’s itolizumab gets clearance in India for restricted emergency use in COVID-19 patients, amid some concerns around small study numbers. But company says data are compelling and cites compassionate use substantiation, while partner Equillium expects to pursue a global study under US IND.
You may also be interested in...
India Grants Controversial Conditional Approvals To Serum, Bharat COVID-19 Vaccines
India has given conditional accelerated approval to AstraZeneca partner Serum Institute, and separately to Bharat Biotech, for their COVID-19 vaccines. With the latter’s candidate still in Phase III trials, the unprecedented decision has caused controversy given the national regulator had earlier said an EUA would not be granted unless trials are completed.
Conditional Approval for Serum, Bharat Bio COVID-19 Vaccines In India Amid Uproar
India gave a conditional accelerated approval to AstraZeneca partner Serum Institute and separately, to Bharat Biotech for their COVID-19 vaccines. With the latter’s vaccine still in Phase III trials, the unprecedented decision caused a flutter as the regulator had earlier said an EUA would not be granted unless trials are completed.
Does The Pandemic Present Opportunities To Rethink Regulatory Approaches?
Biocon chair believes new perspectives on regulatory science and processes emerging from the US's "Warp Speed" efforts to accelerate COVID-19 vaccines have potential for wider application, although Regeneron's president urges caution around relying only on small studies to advance repurposed drugs.