2-73 has already qualified for Fast Track designation for Rett syndrome. It also has Orphan drug designation and Rare Pediatric disease for Rett.
For AD, priority review would effectively replace using the voucher.
I don't know this to be true but I suspect that if Rett is approved prior to NDA submission for AD that the FDA approval process of 2-73 for Rett will speed up the process for AD. The FDA will have recently reviewed the manufacturing data and some other portions of the NDA that are in common between the two submissions.
Just did a bit of research. It appears to me that we are thinking of AA in an incorrect way.
AA does not means the NDA review process is accelerated or shorter. It means that a biomarker is being accepted as evidence of efficacy in circumstances where the evidence otherwise would take years to develop. Think long term survival rate for a cancer drug. That is typically a 5 year period. The biomarker might be significant reduction in tumor size over a 1 year period. AA would get that drug on the market 4 years sooner.
Below is the Lecanemab time line. It used the AA pathway. The reduction on Abeta plaque was used as a biomarker for AD disease progression.
May 9, 2022 Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway.
Jan 6, 2023 Approval FDA Approves Leqembi (lecanemab-irmb) Under the Accelerated Approval Pathway for the Treatment of Alzheimer's Disease
That is a 9 month approval process. The priority review process time line has a 6 month
target.
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