Rezolute says FDA recommends pre-BLA meeting for ersodetug in congenital hyperinsulinism
RZLT•Rezolute said the FDA recommended a Type B pre-BLA meeting ahead of a potential filing for ersodetug. The Phase 3 sunRIZE study showed glycemic improvement but missed its primary endpoint; the FDA did not take a position on approvability.
1. FDA recommends meeting
Rezolute said the FDA recommended a Type B pre-BLA meeting for ersodetug in congenital hyperinsulinism ahead of a potential filing. The FDA reviewed continuous glucose monitoring analyses and did not take a position on approvability.
2. Trial and next results
The Phase 3 sunRIZE study showed glycemic improvement but missed its primary endpoint. Rezolute expects topline Phase 3 upLIFT results in tumor-related hyperinsulinism this quarter, while an open-label extension remains ongoing.
