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FDA recommends pre-BLA meeting for ersodetug in congenital HI despite sunRIZE missing primary endpoint
RZLTRezolute, Inc.
The FDA recommended a pre-BLAs meeting as a precursor to submitting a Biologics License Application (BLA) for ersodetug in congenital hyperinsulinism, following a preliminary review of Phase 3 sunRIZE data. Although the trial missed its primary endpoint due to lack of statistical significance in self-monitored blood glucose reductions, the Agency acknowledged clinically relevant improvements in continuous glucose monitoring metrics and encouraged the BLA submission strategy. Rezolute also expects topline results from the upLIFT study for tumor hyperinsulinism this quarter, which could trigger a separate pre-BLA meeting. The company operates as a late-stage biotechnology firm focused on treating refractory hypoglycemia caused by hyperinsulinism.