Complete Response Letter NDA 505b1 218828 (Dec 19, 2024)
The FDA has identified numerous deficiencies in NDA 218828 for glepaglutide, primarily concerning the interpretability and persuasiveness of efficacy results from clinical trials (EASE-1, EASE-2, EASE-3, EASE-4, ZP1848-15073) and limitations in the safety database. Issues include protocol deviations, incomplete documentation, data reliability concerns, inadequate qualitative and quantitative analyses for clinically meaningful change, lack of confirmatory evidence, and inconsistent dose responses. Furthermore, the safety database is deemed insufficient for a new molecular entity intended for chronic administration, with multiple safety concerns identified and significant reliability issues found during a clinical investigator site inspection. The FDA recommends conducting a new, well-controlled trial to address these deficiencies before resubmission.
