FDA Diabetes Guidance Encourages Enrollment Of Sicker Patients
This article was originally published in The Pink Sheet Daily
Executive SummaryIn raising pre-market safety standards, FDA says that development time will not necessarily increase if a robust protocol is used.
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Agency’s 2008 guidance allows diabetes drug sponsors to exclude a threshold level of increased cardiovascular risk pre-approval through a meta-analysis of clinical trials; however, panelists reviewing Bristol/AstraZeneca’s SGLT-2 inhibitor questioned the usefulness of meta-analyses when they are based primarily upon short-term studies in patients unlikely to have events.
Decreasing cardiovascular events is the only endpoint that matters for cholesterol-lowering drugs, FDA official says at Amarin’s negative Vascepa panel, leaving little room for drug’s expanded approval based on a surrogate endpoint.
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.