Excuses, Excuses: How ‘Delayed’ Confirmatory Trials Are Explained By FDA
US FDA currently reports about two dozen Accelerated Approval having ‘delays’ in the confirmatory trials. COVID is one factor in some – and the agency also appears to be clearing out some of the others.
You may also be interested in...
Of products that have had accelerated approval for at least a decade, just 6% are still marketed without the promised confirmatory evidence. And those include cases like ‘antibiotics approved for inhalational anthrax, where the lack of confirmatory clinical trial is a good thing.’ FDA’s Corrigan-Curay says.
Gilead pulls Zydelig’s third-line indications in follicular B-cell lymphoma and small lymphocytic lymphoma due to confirmatory trial enrollment challenges resulting from an evolving treatment landscape; 13 cancer indications now have been withdrawn since the FDA began cracking down on accelerated approvals that have not confirmed clinical benefit.
When FDA reversed course and allowed Amicus to file for Accelerated Approval of migalastat, plenty of people suspected politics were at play. The agency's handling of the review won’t do anything to allay those suspicions.