FDA recommends pre‑BLA meeting for Rezolute’s ersodetug after Phase 3 congenital HI data review
Rezolute announced that the U.S. Food and Drug Administration has advised the company to seek a Type B pre‑BLA meeting for its ersodetug program aimed at treating congenital hyperinsulinism. The recommendation follows a preliminary review of the Phase 3 sunRIZE trial, which showed glycemic improvements but missed both its primary and key secondary endpoints. Rezolute said it will await topline results from its Phase 3 upLIFT study in tumor hyperinsulinism later this quarter before finalising its BLA strategy.
Why it matters
The company says the FDA’s recommendation allows it to discuss a potential biologics license application, but the agency did not comment on whether the drug could be approved, leaving the ultimate outcome uncertain.
Key facts
- 1The FDA recommended that Rezolute request a Type B pre‑BLA meeting for its ersodetug program targeting congenital hyperinsulinism. globenewswire.com
- 2The Phase 3 sunRIZE trial showed glycemic improvements but did not achieve statistical significance for the primary endpoint of hypoglycemia events measured by finger‑stick glucose. globenewswire.com
- 3The trial also failed to meet the key secondary endpoint of time in hypoglycemia measured by continuous glucose monitoring at Week 24. globenewswire.com
- 4The agency said it would not comment on whether ersodetug could be approved for congenital hyperinsulinism. globenewswire.com
- 5Rezolute expects topline results from its Phase 3 upLIFT study in tumor hyperinsulinism later this quarter. globenewswire.com
- 6The company plans to evaluate its overall BLA submission strategy after the upLIFT results are released. globenewswire.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.