A Pandemic Template For Swift Approval? Veklury Stability Questions Deferred For Later Study

14 Jan 2021

The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.

Close-up of chromatograph with glass sample bottles — veklury stability testing can come after approval, the FDA decides • Source: Shutterstock

The way the US Food and Drug Administration approved Gilead Sciences, Inc.’s Veklury (remdesivir) for COVID-19 before the company could generate key drug substance and drug product batch release and stability data may give industry hope that important treatments for other conditions could win approval before all the data are in, even if their approval is not as urgent.

A key challenge the agency overcame to swiftly approve the nucleotide analog RNA polymerase inhibitor for COVID-19 was the need...