Sp1172
FDA REVIEW OF DUPIXENT (DUPILUMAB) FOR EOSINOPHILIC ESOPHAGITIS
Date
May 9, 2023
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Society: AGA
This session was jointly developed by AGA and representatives from the Division of Gastroenterology at the FDA Center for Drug Evaluation and Research. This session will give health care professionals and clinical trialists a chance to hear directly from FDA representatives about the agency's thinking behind the most recent product approvals and guidance documents impacting the GI community. The 2023 session will address new therapies for IBD, EoE, and C. difficile infection, as well as the agency's current thinking on artificial intelligence-enabled medical devices.
This session was jointly developed by AGA and representatives from the Division of Gastroenterology at the FDA Center for Drug Evaluation and Research. This session will give health care professionals and clinical trialists a chance to hear directly from FDA representatives about the agency's thinking behind the most recent product approvals and guidance documents impacting the GI community. The 2023 session will address new therapies for IBD, EoE, and C. difficile infection, as well as the agency's current thinking on artificial intelligence-enabled medical devices.
Presenter
Tracks
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INTRODUCTION
SOCIETY: AGA
ENCAPSULATED MICROBIOTA TRANSPLANT THERAPY IMPROVES PARTIAL MAYO SCORES IN ULCERATIVE COLITIS AND INDUCES RAPID ENGRAFTMENT COMPARED TO PLACEBO CONTROL
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)…
PLACEHOLDER
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)…
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF PRA023 AS INDUCTION THERAPY IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: ARTEMIS-UC, COHORT 1
Switching from originator to biosimilar infliximab (IFX) is effective and safe. However, data on multiple switching are scarce. The Edinburgh IBD unit has undertaken three switch programmes: (1) Remicade to CT-P13 (2016), (2) CT-P13 to SB2 (2020), and (3) SB2 to CT-P13 (2021)…
