FDA Recommends Pre-BLA Meeting for Rezolute's Congenital HI Drug Ersodetug

Rezolute, Inc. announced that the U.S. Food and Drug Administration (FDA) has recommended the company request a pre-BLA (Biologics License Application) meeting for its drug candidate, ersodetug, for the treatment of congenital hyperinsulinism (HI). This regulatory step forward follows the FDA's review of detailed data from the Phase 3 sunRIZE study, which previously did not meet its primary endpoint but showed clinically relevant improvements.

Key Details

• Regulatory Update: The FDA has encouraged Rezolute to proceed with a pre-BLA meeting as a precursor to a potential BLA submission for ersodetug, despite the drug's Phase 3 sunRIZE trial not meeting its primary endpoint.
• Clinical Context: The FDA's recommendation came after its review of extensive data from the sunRIZE study, acknowledging the challenges in this rare disease patient population and the need for an in-depth evaluation of the totality of evidence.
• Next Steps: Rezolute will evaluate its overall BLA submission strategy following the announcement of topline results from its Phase 3 upLIFT study in tumor HI, which are expected in the current quarter.