Will CV Verdicts For Onglyza, Nesina Cause FDA To Change Its Tune On Antidiabetic Safety?
Large outcomes studies showed neither cardiovascular harm nor benefit with BMS/AstraZeneca’s saxagliptin or Takeda’s alogliptin, prompting some commenters to question whether FDA’s blanket approach to CV safety for all antidiabetic agents needs adjustment.
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Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.
FDA, industry and patient advocates all want studies to move beyond HbA1c, but still need to develop common thresholds and definitions to support patient-reported outcomes in diabetes drug development.
Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.