Pandemic Perspectives: Veklury’s Clinical Development Timeline Compressed By Collaborative Review, Previous Research

The exigencies of the COVID-19 pandemic have driven unprecedented cooperation and creativity in drug development and regulation, but only one therapy for patients infected with SARS-CoV-2 has reached the milestone of US FDA approval as a traditional NDA as well as under emergency use authorization: Gilead Sciences, Inc.’s Veklury (remdesivir). FDA review documents show how the agency used its existing regulatory authorities, especially the fast track designation, to condense clinical and review processes – while at the same time, the World Health Organization was sponsoring its own trial, resulting in conflicting recommendations from two of the world’s foremost health authorities.

Thanks to earlier research against Ebola virus disease and the SARS and MERS coronaviruses, remdesivir was identified early on as a potential COVID-19 candidate. When WHO declared a pandemic on...