Rezolute receives FDA guidance for ersodetug pre-BLA meeting
- Rezolute announced that the FDA recommended a pre-BLA meeting for ersodetug in congenital hyperinsulinism.
- The regulatory recommendation followed a preliminary review of Phase 3 sunRIZE trial data despite missed endpoints.
- The company stated it will evaluate its submission strategy after receiving results from the upLIFT trial.
Rezolute (NASDAQ:RZLT) announced that the U.S. Food and Drug Administration recommended a pre-BLA meeting prior to any potential biologics license application for ersodetug.
The regulatory feedback followed a preliminary review of Phase 3 sunRIZE data in congenital hyperinsulinism, despite the trial missing its primary and key secondary endpoints.
Clinical data showed that reductions in low-blood-sugar events measured by finger-stick testing were not statistically significant compared to placebo.
The continuous glucose monitoring endpoint also missed its week 24 target, though improvements appeared across multiple monitoring-based endpoints.
The biotechnology company noted that the FDA did not assess overall approvability, which requires a formal and complete application review.
Rezolute expects Phase 3 upLIFT results in tumor-related hyperinsulinism this quarter and will evaluate submission strategies for both programs.
