In prior posts this was discussed. Last year FDA said "the FDA cannot approve the application in its present form". I thought it was dead. But it's not, they need it for use in various drug combos they plan. Also the patent for Rux is over in 2028 so they need fresh one.
onclive.com/view/fda-issues...
Looking deeper there were three key criteria,
-Area under the Curve (AUC), "actual body exposure to drug after administration of a dose of the drug"
-C24H (plasma concentration 24 hours after dose) and
- cMax (Max concentration) . "the highest concentration of a drug in the blood (or relevant target location)"
Incyte gambled that FDA would care most about AUC matching regular Rux, and the XR met this. But it failed cMax and c24h and FDA noticed.
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Here is the brief status:
"A bioequivalence study of ruxolitinib extended-release (XR) is enrolling. The data are anticipated in the first half of 2025"
investor.incyte.com/news-re...
This likely the trial. It should be done now but they are still recruiting.
clinicaltrials.gov/study/NC...
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Separately I came across a whole lot of Rux combo studies. Members with MF not responding may want to check these out.
