Diabetes Endpoints, CV Requirements Get Special Handling At FDA-Patient Meeting
Executive Summary
FDA solves citizen petition with first-of-its-kind virtual patient meeting; diabetes group now hopes trifecta of requests will make it from Commissioner’s Office to top CDER officials.
You may also be interested in...
At Liraglutide Panel Review, A Call For CV Studies To Look Beyond MACE
If cardiovascular studies are required for non-cardiac drugs, they should be focused on specific signals of heart-related concern that may not include ischemic events, advisory committee cardiologists say during review of Novo Nordisk’s Saxenda for obesity.
Afrezza Review Shows Need For Patient-Driven Endpoints In Diabetes
Hemoglobin A1c levels are not particularly meaningful to patients more interested in heading off a hypoglycemia event, FDA advisory committee’s patient representative says. Panel votes to approve MannKind’s inhaled insulin despite agency’s efficacy questions and view that a hypoglycemia benefit was not shown.
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.