Post by mnholdem on Aug 28, 2017 8:16:38 GMT -5
Background: The FDA’s Center for Drug Evaluation and Research (CDER) sponsored a public workshop on August 29 on “Diabetes Outcome Measures Beyond Hemoglobin A1c (HbA1c).” The landmark meeting brought together people with diabetes, patient advocates, manufacturers, healthcare providers, researchers, and policymakers – over 900 in-person and online attendees – for a lively day of presentations and discussion on the value of outcomes beyond A1c in diabetes drug regulation.
This workshop was the product of a collaboration between The diaTribe Foundation, the JDRF, the American Diabetes Association, and the American Association of Clinical Endocrinologists. It builds upon a November 2014 FDA event that brought together thousands of people with diabetes and advocates to share valuable patient perspectives with the FDA to better inform the review process for diabetes drugs and devices. Many in attendance emphasized the limitations of A1c numbers alone as the measure of success for treatment and research outcomes. Suggested supplements to A1c included:
- time-in-range
- frequency of low blood sugar (hypoglycemia)
- glucose variability
- weight change
- diabetes burden and more...
The FDA workshop on August 29 aimed to continue this important dialogue and bring patient priorities to the forefront of the FDA’s diabetes drug review process.
For further reading: diatribe.org/public-workshop-outcomes-beyond-a1c-brings-patient-preferences-fda
In early 2017, MannKind Corporation announced that it anticipates a September PDUFA decision on its submittal for re-labeling Afrezza Inhaled Insulin (Insulin Human) to a new class called Ultra Rapid-Acting Insulin [URAI]. Novo-Nordisk recently made a similar submittal for the EMA to create a new class of Ultra Rapid-Acting Analog [URAA] insulin and announced that it plans to submit the same to the FDA.
Future inclusion of additional FDA performance measurements on diabetes drug labeling will have implications, not only for MannKind Corporation, Novo-Nordisk and other pharmaceutical companies, but for the entire diabetes treatment HCP/patient community.
Topic for Discussion: Beginning with sNDA reviews of Afrezza and Fiasp, will the Food & Drug Administration introduce additional performance measurements on diabetes drug labeling than the current emphasis of A1c (HbA1c)?
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Moderator Note: Please share your opinions on this thread, but stay focused on the question of this thread. Posts that go off-topic will be removed.
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but while we're on the subject of getting an upgraded label and pediatric studies and timelines I believe what has not been mentioned is the possibilities with the new regimes in place at both the FDA and MNKD
