FDA Should Require Cardiovascular Outcomes Trials For All Type 2 Diabetes Drugs, Panel Says
This article was originally published in The Pink Sheet Daily
Endocrinologic and Metabolic Drugs Advisory Committee asks the agency to eliminate a degree of risk for all candidates, even if no safety signal emerges from the clinical program.
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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.
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.
In raising pre-market safety standards, FDA says that development time will not necessarily increase if a robust protocol is used.