1. Sotagliflozin has a rollercoaster of a story. I passionately advocated for
    Judy Smith Judy Smith United States says:
    February 16, 2025 at 10:52 PM

    Sotagliflozin has a rollercoaster of a story. I passionately advocated for its FDA approval for my dad in 2024 as adjunctive therapy to insulin for t1d. However, its journey has been tumultuous:
    - 2019: The drug faced an unfortunate setback when the FDA advisory committee had a split vote of 8 yes and 8 no.
    - 2019: Despite advocating for my dad's use of the drug, the struggle continued.
    - 2023: A glimmer of hope appeared when the drug was approved for heart failure management.
    - 2019-2023: Significant evidence emerged with SCORED and SOLOIST-WHF data (on 11,784 patients), leading to USFDA approval for broader HF management.
    - 2024: However, the USFDA endocrine advisory committee rejected the drug with 11 no and 3 yes votes, citing that risks outweigh the benefits, just like in 2019.
    - 2019-2024: A troubling comparison of votes shows 8-8 (2019) vs 11-3 (2024) 🤔
    - 2025: New evidence and analysis revealed that Sotagliflozin reduces ischemic events, not just heart failure. The benefits are distinct from other popular SGLT2 inhibitors commonly used for diabetes, heart failure, and kidney disease.

    It’s hard to comprehend the reasoning behind the FDA advisory committee’s repeated rejection despite mounting evidence of the drug’s benefits. This new evidence is a game-changer, yet it seems the decision-makers are stuck in a cycle of doubt. 🤔

    Reply
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